Back to resultsLong Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
Primary Purpose
Chronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NSAID
Tanezumab 2.5 mg
Tanezumab 5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
- Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
- WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
- Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
- Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements
Exclusion Criteria:
- Subjects exceeding protocol defined BMI or body weight limits
- History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
- Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
- A history of osteonecrosis or osteoporotic fracture
- History of significant trauma or surgery to a knee, hip or shoulder within the previous year
- Planned surgical procedure during the duration of the study
- Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
- Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
- Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
- Contraindications to magnetic resonance imaging
- History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated
- History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
- Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period
- History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol
- Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities
- History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy
- History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
- History of known alcohol, analgesic or drug abuse within 2 years of Screening
- Previous exposure to exogenous NGF or to an anti-NGF antibody
- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein
- Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening
- Evidence of protocol defined orthostatic hypotension at Screening
- Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
- Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits
- Presence of drugs of abuse in screening urine toxicology panel
- Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
- Participation in other investigational drug studies within protocol defined time limits
- Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study
Sites / Locations
- Central Alabama Research
- Achieve Clinical Research, LLC
- Alabama Clinical Therapeutics, LLC
- Alabama Orthopaedic Surgeons
- Rheumatology Associates of North Alabama, PC
- Coastal Clinical Research, Inc.
- Ferguson Family Medicine
- Arizona Arthritis & Rheumatology Associates, P.C.
- Arizona Research Center
- Valley Pain Consultants
- Clinical Research Consortium
- Noble Clinical Research, LLC
- Quality of Life Medical & Research Centers, LLC
- Tucson Orthopaedic Institute - Research Center
- CHI St. Vincent Medical Group Hot Springs
- Chrystal Johnson
- KLR Business Group, Inc., dba Arkansas Clinical Research
- Larry Watkins, MD
- Lynn Institute of the Ozarks
- Orange County Research Institute
- Advanced Research Center
- CITrials
- Osteoporosis Medical Center
- Hope Clinical Research
- Med Center
- Core Healthcare Group
- Pleitez Medical Clinic
- Triwest Research Associates, LLC
- T. Joseph Raoof MD, INC/Encino Research Center
- San Diego Imaging Escondido
- Med Investigations, Inc.
- Research Center of Fresno, Inc.
- Neuro-Pain Medical Center
- Collaborative Neuroscience Network, LLC.
- Allied Clinical Research
- HealthCare Partners Clinical Research, LLC.
- Marvel Clinical Research LLC
- BioSolutions Clinical Research Center
- eStudySite
- Arthritis & Osteoporosis Medical Center
- Center For United Research, Inc.
- Collaborative Neuroscience Network, LLC.
- Aeon Research, Inc.
- American Institute of Research
- InterMed Medical Group
- IMD Medical Group
- Catalina Research Institute, LLC
- Providence Clinical Research
- Renaissance Imaging Medical Associates, Inc
- NRC Research Institute
- Advances in Medicine
- Probe Clinical Research Corporation
- University of California, Davis Health System
- University of California, Davis Medical Center
- Clinical Trials Research
- Northern California Research
- Center for Clinical Trials of Sacramento, Inc.
- Artemis Institute for Clinical Research
- San Diego Imaging, Kearny Mesa
- Sharp and Children's MRI Center, LLC
- Artemis Institute for Clinical Research
- CITrials
- Syrentis Clinical Research
- Shariar Cohen, MD Corp.
- Westlake Medical Research
- Bayview Research Group
- Renaissance Imaging Medical Associates, Inc
- Buhay & Maglunog MDS
- Prohealth Advanced Imaging
- Advanced Rx Clinical Research Group, Inc
- Medvin Clinical Research
- Elite Clinical Trials
- Mountain View Clinical Research, Inc.
- Mountain View Clinical Research, Inc
- New England Research Associates, LLC
- Clinical Research Center of CT
- Stamford Therapeutics Consortium
- Delaware Arthritis
- Javed Rheumatology Associates, Inc.
- JEM Research Institute
- AARDS Research, Inc.
- RASF-Clinical Research, Inc
- Orthopedic Research Institute
- Meridien Research
- Orthopaedic Associates of West Florida
- Tampa Bay Medical Research, Inc
- Midland Florida Clinical Research Center, LLC
- S&W Clinical Research
- Centre for Rheumatology, Immunology and Arthritis
- Clinical Physiology Associates
- IMA
- SIMEDHealth, LLC
- South Florida Clinical Trials
- Pines Clinical Research Inc.
- Jacksonville Center for Clinical Research
- Care Partners Clinical Research
- Clinical Neuroscience Solutions, Inc.
- Columbus Clinical Services LLC
- Pharmax Research Clinic, Inc.
- Clintex Research Group
- Center for Arthritis and Rheumatic Diseases
- Larkin Imaging Center
- New Horizon Research Center
- International Research Associates, LLC
- M&M Medical Center, Inc.
- Quality Research & Medical Center LLC
- Renstar Medical Research
- American Family Medical
- Sensible Healthcare, LLC.
- Journey Research, Inc.
- Sunshine Research Center
- Compass Research, LLC
- Rheumatology Associates of Central Florida, P.A.
- Omega Research Consultants, LLC
- Oviedo Medical Research, LLC
- Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center
- Sacred Heart Orthopedics
- Orthopaedic Center of South Florida
- St. Johns Center for Clinical Research
- Progressive Medical Research
- Accord Clinical Research, LLC
- Meridien Research
- Gulfcoast Research Institute, LLC
- Kennedy White Orthopaedic Center
- Precision Clinical Research, LLC.
- Phoenix Clinical Research, LLC.
- Clinical Research of West Florida, Inc.
- Stedman Clinical Trials
- BayCare Medical Group, Inc
- Compass Research North LLC
- Palm Beach Research Center
- Atlanta Center for Medical Research
- Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic
- Masters of Clinical Research, Inc.
- River Birch Research Alliance, LLC
- Arthritis Center of North Georgia
- Center for Advanced Research & Education
- Drug Studies America
- Better Health Clinical Research, Inc.
- Atlanta Orthopaedic Institute, LLC
- Herman Clinical Research, LLC
- North Georgia Clinical Research
- North Georgia Internal Medicine
- East-West Medical Research Institute
- Idaho Sports Medicine Institute
- Injury Care Research, LLC
- Institute Of Arthritis Research
- Advanced Clinical Research
- Medex Healthcare Research, Inc.
- Chicago Clinical Research Institute Inc.
- Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center
- Northwestern University Feinberg School of Medicine
- Rush University Medical Center
- Great Lakes Clinical Trials
- Affinity Clinical Research Institute
- Southwest Center for Healthy Joints, S.C.
- Methodist Research Administration Office
- UnityPoint Clinic Rheumatology
- Methodist Medical Center of Illinois
- OrthoIllinois
- Quest Diagnostics
- MediSphere Medical Research Center, LLC
- Buynak Clinical Research, P.C.
- Mid-America Physiatrists, P.A.
- Phoenix Medical Research, Inc.
- Professional Research Network of Kansas, LLC
- Heartland Research Associates, LLC
- Otrimed Corporation
- Central Kentucky Research Associates, Inc.
- Baton Rouge General Medical Center-Internal Medicine Clinic
- Baton Rouge General Medical Center-Midcity
- Baton Rouge General Medical Center-Bluebonnet
- Baton Rouge General Medical Center-Clinical Trials Office
- Centex Studies, Inc.
- Klein & Associates, M.D., P.A.
- Arthritis Treatment Center
- Klein & Associates, M.D., P.A.
- The Center for Rheumatology and Bone Research
- Beacon Clinical Research, LLC
- MedVadis Research Corporation
- Great Lakes Research Group, Incorporated
- Onyx Clinical Research
- Orthopaedic Associates of Michigan, PC
- June D.O. PC
- Great Lakes Research Group
- Michigan Orthopaedic Spine Surgeons
- Medical Research Associates Inc.
- Oakland Medical Research Center
- Olive Branch Family Medical Center
- Landmark Internal Medicine
- University of Missouri Health Care-Investigational Pharmacy
- University of Missouri Health Care
- University of Missouri School of Medicine- Clinical Research Center
- Advance Clinical Research, Inc.
- Medex Healthcare Research, Inc.
- Physician Research Collaboration, LLC
- Affiliated Clinical Research, Inc.
- Impact Clinical Trials
- Office of Stephen H. Miller, MD
- Clinical Research Consortium
- Office of Robert P. Kaplan, DO
- Advanced Biomedical Research of America
- G. Timothy Kelly, MD
- ActivMed Practices & Research, Inc.
- Ocean Rheumatology, PA
- Premier Research
- Arthritis, Rheumatic and Back Disease Associates, PA
- Albuquerque Clinical Trials, Inc.
- New Mexico Clinical Research & Osteoporosis Center, Inc.
- Lovelace Scientific Resources Inc.
- NYU Langone Ambulatory Care Brooklyn Heights
- Drug Trials Brooklyn
- SPRI Clinical Trials, LLC
- Drug Trials America
- NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center
- NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center
- NYU Langone Rheumatology Associates Long Island
- Lenox Hill Radiology
- Manhattan Medical Research Practice PLLC
- The Medical Research Network, LLC
- AAIR Research Center
- Upstate Clinical Research Associates, LLC
- Northstate Clinical Research, PLLC
- Wake Internal Medicine Consultants, Inc
- Wake Research Associates, LLC
- The Center for Clinical Research
- Lillestol Research, LLC
- Plains Clinical Research Center, LLC
- Valley Medical Research/Valley Medical Primary Care
- Hightop Medical Research Center
- New Horizons Clinical Research
- CTI Clinical Research Center
- Aventiv Research Inc.
- Remington-Davis, Incorporated
- Optimed Research LTD
- Dayton Clinical Research
- PriMed Clinical Research
- Kettering Medical Center
- Springboro Health Center
- AC Clinical Research
- Glendale Medical Center
- Bone Joint & Spine Surgeons, Inc.
- Health Research of Oklahoma
- Lynn Health Science Institute
- University Orthopedics Center
- Heritage Valley Medical Group, Inc.
- Brandywine Clinical Research
- Altoona Center for Clinical Research
- The Clinical Trial Center LLC
- Founders Research Corporation
- The Arthritis Group
- Clinical Research Center of Reading, LLC
- Main Street Physician's Care - Waterway
- Main Street Physician's Care - Loris
- North Myrtle Beach Family Practice
- Clinical Research Solutions
- Physicians Quality Care
- PMG Research, Inc. d/b/a PMG Research of Knoxville
- PCET Research Center, LLC
- Diagnostic Imaging PC
- ARC Clinical Research at Wilson Parke
- Tekton Research, Inc.
- Urgent Care MD's
- Texas Orthopedic Specialists, PLLC
- Galenos Research
- Abigail R. Neiman, MD, PA
- Advances in Health
- Mercury Clinical Research, Inc.
- Centex Studies, Inc.
- Memorial Pulmonology
- BI Research Center
- Clinical Investigations of Texas
- ClinRX Research
- Quality Research, Inc.
- Lee Medical Associates PA
- Progressive Clinical Research, PA
- Sun Research Institute
- Panacea Clinical Research
- Accurate Clinical Research Inc.
- Diagnostics Research Group
- Victorium Clinical Research
- DCT-Stone Oak, LLC dba Discovery Clinical Trials
- South Texas Radiology Imaging Centers
- Envision Imaging
- Oakbend Medical Center
- ClinPoint Trials
- Mercury Clinical Research
- Clinics of North Texas
- Grayline Clinical Drug Trials
- Granger Medical Clinic-Riverton
- Millennium Clinical Trials, LLC
- Charlottesville Medical Research Center, LLC
- Millennium Clinical Trials
- National Clinical Research-Norfolk, Inc.
- Northwest Clinical Research Center
- Optimed Research, LTD
- Swedish Medical Center Investigational Drug Services Pharmacy
- Seattle Rheumatology Associates
- Swedish Medical Center
- Genesis Research Services
- Hunter Imaging Group
- Optimus Clinical Research Pty Ltd
- Southern Radiology
- Royal Hospital for Women
- Castlereagh Imaging
- Royal North Shore Hospital
- Australian Clinical Research Network
- Spectrum Medical Imaging
- AusTrials Pty Ltd
- CMAX Clinical Research Pty Ltd
- Royal Adelaide Hospital Pharmacy
- Bensons Radiology
- Emeritus Research
- Capital Radiology-Malvern
- Capital Radiology-Clayton
- SKG Radiology Hollywood
- RK Will Pty Ltd
- CMIP-Centro Mineiro de Pesquisa LTDA
- CCBR - Centro de Pesquisas e Analises Clinicas LTDA
- CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
- Diagnostic Consultative Center "Sveti Georgi" EOOD
- Medical Center "Health for all" - EOOD
- UMHAT Kaspela - EOOD Rheumatology Clinic
- UMHAT Kaspela - EOOD
- "Medical Center Teodora" EOOD
- Diagnostic Consultative Center 17 Sofia EOOD
- UMHAT Sveti Ivan Rilski- EAD
- UMHAT "Sofiamed" OOD, Block 2
- "Medical Center- Dr. Hayvazov" EOOD
- Centro Integral de Reumatologia Reumalab S.A.S.
- Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS
- Medicinski centar Kuna&Peric
- National Hospital Organization Toyohashi Medical Center
- Funabashi Municipal Medical Center
- Matsudo City General Hospital
- Kanbara Clinic
- Hidaka Orthopedic Hospital
- Obase Hospital
- Himeno Hospital
- Ikeda Kinen Hospital
- Zenshukai Hospital
- Mazda Hospital
- Medical Corporation Okimoto Clinic
- Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital
- Takahashi Orthopedics Clinic
- Obihiro Orthopaedic Hospital
- Okubo Hospital
- Omuro Orthopedic Clinic
- Medical corporate corporation hoshikai Onishi medical clinic
- Kobe Red Cross Hospital
- Mito Saiseikai General Hospital
- National Hospital Organization Kanazawa Medical Center
- Kokan Clinic
- Misugikai Medical Corporation Otokoyama Hospital
- Nakajo Orthopedic Clinic
- Marunouchi Hospital
- Oita University Hospital
- Sobajima Clinic/Orthopedics
- Rinku General Medical Center
- Kishiwada Tokushukai Hospital
- Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital
- Osaka University Hospital
- Shimane University Hospital
- Fujieda Municipal General Hospital
- JA Shizuoka Kohseiren Enshu Hospital
- Japanese Red Cross Hamamatsu Hospital
- Sonodakai Joint Replacement Center Hospital
- Medical Plaza Edogawa
- Sato Orthopaedic Clinic
- Fussa Hospital
- Jukoukai hospital
- Kitasato University Kitasato Institute Hospital
- Tamagawa Hospital
- Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
- Ohimachi Orthopaedic Clinic
- Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
- National Hospital Organization Chiba Medical Center
- Chihaya Hospital
- Kuroda Orthopedic Hospital
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
- Hiroshima Prefectural Hospital
- Kumamoto Orthopaedic Hospital
- Nagayoshi General Hospital
- Iwasaki Orthopedic Surgery
- Saitama Municipal Hospital
- Daegu Catholic University Medical Center
- Department of Radiology
- Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center
- Chungnam National University Hospital
- Clinical Trial Center Pharmacy
- Department of Radiology
- Chonnam National University Hospital
- Department of Radiology
- Pharmacy of Clinical Trial Center
- Clinical Trial Pharmacy
- Department of Radiology
- Korea University Anam Hospital
- Clinical Trials Center Pharmacy
- Seoul National University Hospital
- Clinical Trial Center Pharmacy
- Department of Radiology
- Yonsei University Health System, Severance Hospital
- Clinical Research Pharmacy
- Department of Clinical Research Pharmacy, Konkuk University Medical Center
- Department of Radiology
- Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center
- Konkuk University Medical Center
- Clinical Trial Center Pharmacy
- Department of Orthopedic Surgery, Samsung Medical Center
- Clinical Trial Pharmacy
- Department of Radiology
- The Catholic University of Korea Seoul St. Mary's Hospital
- Clinical Research Pharmacy, SMG SNU Boramae Medical Center
- Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center
- Department of Radiology
- SMG-SNU Boramae Medical Center
- Department of Radiology
- Ewha Womans University Mokdong Hospital
- Clinical Trial Pharmacy
- Saules seimos medicinos centras
- Klaipeda University Hospital
- Republican Siauliai Hospital
- Centro Hospitalario Mac, S.A. de C.V.
- Consultorio Medico del Dr. Federico Galvan Villegas
- Lakeland Clinical Trials
- Otago Radiology
- RMC Medical Research Ltd
- South Pacific Clinical Trials
- TRG Imaging Lincoln Road
- Auckland Bone Density Ltd
- North Shore Hospital, Waitemata District Health Board
- Star Unit, North Shore Hospital, Waitemata District Health Board
- The Radiology Group
- Southern Clinical Trials- Waitemata Ltd
- Auckland Bone Density
- Optimal Clinical Trials
- Auckland Radiology Parnell Branch
- Southern Clinical Trials Ltd
- Collingwood Street Pharmacy
- Nelson Radiology
- Porter Rheumatology Ltd
- Bay Radiology
- P3 Research Ltd
- Clinical Horizons NZ Ltd
- P3 Research Ltd
- Pacific Radiology
- Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
- Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.
- ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.
- Centro de Investigación Reumatología CAA-Clinica Anglo Americana
- Investigaciones en Reumatologia / Centro Medico Corpac S.A.
- Centro de Investigaciones Medicas-Hospital Maria Auxiliadora
- Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.
- Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.
- Philippine General Hospital
- Manila Doctors Hospital
- Moscow Municipal Rheumatology Center
- SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"
- SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"
- Federal State Budgetary Scientific Research institution of fundamental and clinical immunology
- Federal State Budgetary Scientific Institution
- State Budgetary Institution of Ryazan Region
- Medical Technologies Ltd
- Limited Liability Company "Medical Center "Reavita Med SPb"
- Medinet LLC
- FSBI 'SRITO n.a. R.R. Vreden' MoH RF
- Institute for Rehabilitation
- Institute of Rheumatology
- Institute for treatment and rehabilitation "Niska Banja"
- Special Hospital for Rheumatic Diseases Novi Sad
- General hospital "Dr Laza K. Lazarevic" Sabac
- Reumatologia s.r.o.
- Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves
- MUDr. STRANAI s.r.o.
- Reum.hapi s.r.o.
- MEDIPA s.r.o.
- Thermium s.r.o.
- Changhua Christian Hospital Clinical Trial Pharmacy
- Changhua Christian Hospital
- Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy
- Chang Gung Memorial Hospital-Kaohsiung Branch
- Chung Shan Medical University Hospital Clinical Trial Pharmacy
- Chung Shan Medical University Hospital
- China Medical University Hospital
- Department of Pharmacy, China Medical University Hospital
- Regional Communal Institution Chernivtsi Regional Clinical Hospital
- Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council
- Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
- Chair of Internal Medicine #2
- Oleksandrivska Clinical Hospital Of Kyiv
- Kyiv City Clinical Hospital 3,Rheumatology Department
- Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,
- Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company
- Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"
- Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine
- National Medical University named after O O Bogomolets,
- Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem
- Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department
- Communal Institution "Odesa Regional Clinical Hospital"
- Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,
- Communal Institution Ternopil University Hospital
- Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,
- Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"
- Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD
- Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical
- Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3
- Communal Institution Zaporizhzhya Regional Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
NSAID
Tanezumab 2.5 mg
Tanezumab 5 mg
Arm Description
Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks
Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Secondary Outcome Measures
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Percentage of Participants With Individual Adjudicated Joint Safety Outcome
Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function.
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Pain Subscale at Week 64
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in WOMAC Physical Function Subscale at Week 64
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56
Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Change From Baseline in Average Pain Score in the Index Joint at Week 64
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain
Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain
Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain
Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain
Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain
Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses
TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?
The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.
Number of Participants Who Withdrew Due to Lack of Efficacy
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Time to Discontinuation Due to Lack of Efficacy
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Number of Participants Who Took Rescue Medication During Week 64
In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Number of Days of Rescue Medication Used During Week 64
In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80
The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0).
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56
Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.
Change From Baseline in Average Daily Step Count at Weeks 16 and 56
Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20.
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1.
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Heart rate (pulse rate) was measured at sitting position.
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80
Heart rate was measured at sitting position.
Number of Participants With Confirmed Orthostatic Hypotension
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Number of Participants With Anti-Tanezumab Antibodies
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02528188
Brief Title
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
Official Title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the long-term joint safety and efficacy (pain relief) of the investigational study drug, tanezumab compared to non-steroidal anti inflammatory drugs (NSAIDs) in subjects with osteoarthritis of the hips or knees.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3021 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSAID
Arm Type
Active Comparator
Arm Description
Subcutaneous injection of placebo for tanezumab every 8 weeks plus oral NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Arm Title
Tanezumab 2.5 mg
Arm Type
Experimental
Arm Description
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac ER) twice daily for 56 weeks
Arm Title
Tanezumab 5 mg
Arm Type
Experimental
Arm Description
Subcutaneous injection of tanezumab 5 mg every 8 weeks plus oral placebo for NSAID (naproxen, celecoxib or diclofenac) twice daily for 56 weeks
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
Intervention Type
Biological
Intervention Name(s)
Tanezumab 2.5 mg
Intervention Description
Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
Intervention Type
Biological
Intervention Name(s)
Tanezumab 5 mg
Intervention Description
Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Adjudicated Primary Composite Joint Safety Outcome
Description
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive osteoarthritis (OA) type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of joint space width (JSW) (greater than or equal to [>=] 2 millimeters [mm]) within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time Frame
Baseline up to Week 80
Title
Observation Time-Adjusted Event Rate of Participants With Adjudicated Primary Composite Joint Safety Outcome
Description
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Primary joint safety outcome included participants with adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time Frame
Baseline up to Week 80
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions, which may not be a whole (integer) number, scored on a numerical rating scale (NRS). Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 16
Description
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using Interactive Response Technology (IRT), where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Description
Any participant with incidence of an adjudicated outcome of primary osteonecrosis, rapidly progressive OA type 2, subchondral insufficiency fracture, or pathological fracture. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time Frame
Baseline up to Week 80
Title
Observation Time-Adjusted Event Rate of Participants With Adjudicated Secondary Composite Joint Safety Outcome
Description
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Secondary joint safety outcome included primary osteonecrosis, rapidly progressive OA (type-2), subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time Frame
Baseline up to Week 80
Title
Percentage of Participants With Individual Adjudicated Joint Safety Outcome
Description
Any participant with incidence of an adjudicated outcome of rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Rapidly progressive OA type 1 events were those that the Adjudication Committee considered to have significant loss of JSW >=2 mm within approximately 1 year without gross structural failure. Rapidly progressive OA type 2 events were those considered to have abnormal loss/destruction of bone including limited or total collapse of at least one subchondral surface (e.g., medial femoral condyle) that is not normally present in conventional end-stage OA.
Time Frame
Baseline up to Week 80
Title
Observation Time-Adjusted Event Rate of Participants With Individual Adjudicated Joint Safety Outcome
Description
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Individual joint safety outcome included rapidly progressive OA (type-1 only), rapidly progressive OA (type-2 only), rapidly progressive OA (type-1 or type-2 combined), subchondral insufficiency fracture, primary osteonecrosis, and pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time Frame
Baseline up to Week 80
Title
Percentage of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Description
Percentage of participants with total joint replacement (hip, knee or shoulder) or adjudicated primary composite joint safety outcomes were reported. Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture.
Time Frame
Baseline up to Week 80
Title
Observation Time-Adjusted Event Rate of Participants With Total Joint Replacement or Adjudicated Primary Composite Joint Safety Outcome
Description
Observation time was defined as the start day of first SC study medication until either the (i) date of completion of or withdrawal from study, if a participant did not have the event, or (ii) date of the event (earliest event within each participant in the case of multiple events). Adjudicated primary composite joint safety outcomes included primary osteonecrosis, rapidly progressive OA type 1 or type 2, subchondral insufficiency fracture, or pathological fracture. Event rate was calculated as the number of events per 1000 participant-years at risk.
Time Frame
Baseline up to Week 80
Title
Change From Baseline in Medial or Lateral Joint Space Width of the Index Knee (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Description
Change from baseline in JSW was defined as change in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the medial and lateral tibiofemoral of knee in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral).
Time Frame
Baseline, Weeks 56 and 80
Title
Change From Baseline in Joint Space Width of the Index Hip (Kellgren-Lawrence Grade 2 or 3) at Weeks 56 and 80
Description
Change from baseline in JSW was defined as narrowing in JSW compared to baseline in participants with Kellgren-Lawrence grade 2 or 3 over the course of the study. It was measured radiographically in the index hip in participants with OA. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Time Frame
Baseline, Weeks 56 and 80
Title
Number of Participants With Progression of Osteoarthritis in the Index Knee (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Description
Progression of OA according to Bland-Altman as defined by a decrease JSW >=1.96 times within-participant standard deviation of change in JSW. The number of participants with progression of OA in the index knee are summarized separately by the compartment of OA at baseline (medial or lateral). Kellgren-Lawrence grade system was a method of classifying the severity of knee OA using five grades i.e. 0 [no radiographic features of OA], 1 [doubtful joint space narrowing (JSN) and possible osteophytic lipping], 2 [definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph], 3 [multiple osteophytes, definite JSN, sclerosis, possible bony deformity], 4 [large osteophytes, marked JSN, severe sclerosis and definite bony deformity]. Higher grade indicating worse knee function.
Time Frame
Weeks 56 and 80
Title
Number of Participants With Progression of Osteoarthritis in the Index Hip (Kellgren-Lawrence Grade 2 or 3) According to Bland and Altman Method at Weeks 56 and 80
Description
Progression of OA according to Bland-Altman methodology as defined by a decrease in JSW >=1.96 times within-participant standard deviation of the change in JSW in the index hip. The number of participants with progression of OA in the index hip per Bland-Altman methodology are reported. Kellgren-Lawrence grade system was a method of classifying the severity of hip OA using five grades i.e. 0 (no radiographic features of OA), 1 (doubtful JSN and possible osteophytic lipping), 2 (definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph), 3 (multiple osteophytes, definite JSN, sclerosis, possible bony deformity), 4 (large osteophytes, marked JSN, severe sclerosis and definite bony deformity). Higher grade indicating worse hip function.
Time Frame
Weeks 56 and 80
Title
Change From Baseline in WOMAC Pain Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Title
Change From Baseline in WOMAC Pain Subscale at Week 64
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS, which may not be a whole (integer) number. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 64
Title
Change From Baseline in WOMAC Physical Function Subscale at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time Frame
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Title
Change From Baseline in WOMAC Physical Function Subscale at Week 64
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions, which may not be a whole (integer) number, scored on a NRS. Scores for each question and WOMAC physical function subscale score on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Description
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time Frame
Baseline, Weeks 2, 4, 8, 24, 32, 40, 48 and 56
Title
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 64
Description
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip (index joint) affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, using IRT, where 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5= very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Time Frame
Baseline, Week 64
Title
Percentage of Participants Meeting Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Description
Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was >=50 percent and >= 2 units in either WOMAC pain subscale or physical function subscale score; if change (improvement) from baseline to week of interest was >=20 percent and >=1 unit in at least 2 of the following: 1) WOMAC pain subscale score, 2) WOMAC physical function subscale score, 3) PGA of OA. WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and PGA of OA (score: 1 [very good] to 5 [very poor], higher score = worse condition). Missing data was imputed using mixed baseline/last observation carried forward (BOCF/LOCF).
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Title
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Description
Percentage of participants with reduction in WOMAC pain intensity of >= 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64 compared to baseline were classified as responders to WOMAC pain subscale and are reported here. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint (knee or hip) during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Missing data was imputed using mixed BOCF/LOCF.
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Title
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16, 24 and 56
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to OA of index joint during past 48 hours. It was calculated as the mean of scores from 5 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale score on NRS ranged from 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain. Percentage of participants with cumulative reduction (as percent) (greater than [>] 0% ; >= 10, 20, 30, 40, 50, 60, 70, 80 and 90%; = 100 %) in WOMAC pain subscale from Baseline to Weeks 16, 24 and 56 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.
Time Frame
Baseline, Weeks 16, 24 and 56
Title
Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction of >=30%, >=50%, >=70% and >=90% Response at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Description
Percentage of participants with reduction in WOMAC physical function of >=(30%,50%,70%,90%) at Weeks 2,4,8,16,24,32,40,48,56 and 64 compared to baseline were classified as responders to WOMAC physical function subscale. WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function:Participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale17-item questionnaire used to assess the degree of difficulty experienced due to OA in index joint (knee/hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC physical subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicated extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Title
Percentage of Participants With Cumulative Percent Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16, 24 and 56
Description
Percentage of participants with cumulative reduction (as percent) (> 0 %; >= 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80% and 90%; =100%) in WOMAC physical function subscale from baseline to Weeks 16, 24 and 56 were reported. WOMAC:Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Physical function: participant's ability to move around and perform usual activities of daily living. WOMAC physical function subscale:17-item questionnaire to assess the degree of difficulty experienced due to OA in index joint (knee or hip) during past 48 hours, calculated as mean of the scores from 17 individual questions scored on a NRS. Scores for each question and WOMAC Pain subscale on NRS ranged from 0 (no difficulty) to 10 (extreme difficulty), higher scores indicate extreme difficulty/worse physical function. Missing data was imputed using mixed BOCF/LOCF.
Time Frame
Baseline, Weeks 16, 24 and 56
Title
Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Description
PGA of OA was assessed by asking a question from participants: "Considering all the ways your OA in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1-5, where, 1=very good (no symptom and no limitation of normal activities), 2= good (mild symptoms and no limitation of normal activities), 3= fair (moderate symptoms and limitation of some normal activities), 4= poor (severe symptoms and inability to carry out most normal activities), and 5 = very poor (very severe symptoms and inability to carry out all normal activities). Higher scores indicated worse condition. Percentage of participants with improvement of at least 2 points from baseline in PGA of OA were reported. Missing data was imputed using mixed BOCF/LOCF.
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56 and 64
Title
Change From Baseline in Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Description
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data for Weeks 20 through 56 represents averages of the values reported during the 4-week interval up to and including the given week. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 32, 40, 48 and 56
Title
Change From Baseline in Average Pain Score in the Index Joint at Week 64
Description
Participants assessed their average pain in the index hip/knee in the past 24 hours using NRS, with a scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicated higher pain. Data represents averages of the values reported during the 4-week interval up to and including Week 64. Change from baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 64
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. Stiffness was defined as a sensation of decreased ease of movement in the index joint (knee or hip). The WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to OA in the index joint (knee or hip) during the past 48 hours. It was calculated as the mean of scores from 2 individual questions scored on NRS. Scores for each question and WOMAC stiffness subscale score on NRS ranged from 0 (no stiffness) to 10 (extreme stiffness), where higher scores indicated higher stiffness.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 64
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA of index joint (knee or hip). WOMAC pain subscale assess amount of pain experienced (score: 0 [no pain] to 10 [extreme pain], higher score = more pain), WOMAC physical function subscale assess degree of difficulty experienced (score: 0 [no difficulty] to 10 [extreme difficulty], higher score = worse physical function) and WOMAC stiffness subscale assess the amount of stiffness experienced (score: 0 [no stiffness] to 10 [extreme stiffness], higher score = higher stiffness). WOMAC average score was the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, where higher scores indicated worse response.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 64
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when walking on a flat surface?". Participants responded about the amount of pain they experienced when walking on a flat surface by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Down Stairs at Week 64
Description
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA in index joint (knee or hip). Participants answered a question: "How much pain have you had when going up or down the stairs?" Participants responded about the amount of pain they experienced when going up or down stairs by using a NRS of 0 (no pain) to 10 (extreme pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 64
Title
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Weeks 16, 24 and 56
Description
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Time Frame
Weeks 16, 24 and 56
Title
Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Week 64
Description
WPAI is 6-question participant rated questionnaire to determine the impact of OA on absenteeism, presenteeism, work productivity, and daily activity impairment for a period of 7 days prior to a visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism), overall work impairment (work productivity) and activity impairment (daily activity impairment). These sub-scores are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.
Time Frame
Baseline, Week 64
Title
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Mobility Domain
Description
Number of participants with mobility domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Self-Care Domain
Description
Number of participants with self-care domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Usual Activities Domain
Description
Number of participants with usual activities domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Pain/Discomfort Domain
Description
Number of participants with pain/discomfort domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
Number of Participants With Responses to European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L): Anxiety/ Depression Domain
Description
Number of participants with anxiety/ depression domain responses of EQ-5D-5L were provided. EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Higher scores indicated greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score/Index Value
Description
EQ-5D-5L: standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional VAS. EQ-5D health state profile comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Responses from the five domains were used to calculate a single utility index (the Overall health utility score) where values are less than or equal to (<=) 1. The Overall health utility score for a participant with no problems in all 5 items is 1 for all countries (except for Zimbabwe where it is 0.9), and is reduced where a participant reports greater levels of problems across the five dimensions.
Time Frame
Baseline, Weeks 8, 16, 24, 40, 56 and 64
Title
Treatment Satisfaction Questionnaire Medicine Version II (TSQM v.II) Score With Effectiveness, Side Effects, Convenience, and Overall Satisfaction Responses
Description
TSQM v.II is a self-administered 11-item validated scale that quantified participant's level of satisfaction with study medication (scored on a 7-point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=dissatisfied, 4=somewhat satisfied, 5=satisfied, 6=very satisfied, 7=extremely satisfied]) and dissatisfaction with side effects (3 questions scored on 5 point Likert scale [1= extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=slightly dissatisfied, 5=not at all dissatisfied] and 1 question on 2 point scale [0 =No, 1=Yes]). Participants were asked to assess their level of satisfaction taking all things into account. The 11 questions of the TSQM were used to calculate the 4 endpoints of effectiveness, side Effects, convenience and global satisfaction, each scored on a 0-100 scale with 100 being the best level of satisfaction.
Time Frame
Weeks 16 and 56
Title
Patient-Reported Treatment Impact Assessment- Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving for Osteoarthritis Pain Before Enrolling?
Description
The mPRTI is a self-administered questionnaire containing participant's global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant's willingness to use drug again assessment. To assess current or most recent treatment, participants responded for, 1=injectable prescription medicines, 2=prescription medicines taken by mouth, 3=surgery, 4=prescription medicines and surgery and 5=no treatment. Number of participants who responded for the specified question were reported.
Time Frame
Weeks 16 and 56
Title
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Global Preference Assessment- Overall, do You Prefer the Drug That You Received in This Study to Previous Treatment?
Description
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess preference to continue using the investigational product, participants responded using IRT on a 5 point Likert scale from 1-5, where, 1= yes, I definitely prefer the drug that I am receiving now, 2= I have a slight preference for the drug that I am receiving now, 3= I have no preference either way, 4= I have a slight preference for my previous treatment, 5= No, I definitely prefer my previous treatment. Higher scores indicate lesser preference to use the investigational product. Number of participants who responded for the specified question were reported.
Time Frame
Weeks 16 and 56
Title
Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 56: Participant Willingness to Use Drug Again Assessment- Willing to Use the Same Drug That You Have Received in This Study for Your Osteoarthritis Pain?
Description
The mPRTI is a self-administered questionnaire containing participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. To assess participant willingness to use drug again, participants responded using IRT on a 5 point likert scale from 1-5, where, 1= yes, I would definitely want to use the same drug again, 2= I might want to use the same drug again, 3= I am not sure, 4= I might not want to use the same drug again, 5= no, I definitely would not want to use the same drug again. Higher scores indicate lesser willingness to use the investigational product. Number of participants who responded for the specified question were reported.
Time Frame
Weeks 16 and 56
Title
Number of Participants Who Withdrew Due to Lack of Efficacy
Description
Number of participants who withdrew from treatment due to lack of efficacy have been reported here.
Time Frame
Baseline up to Week 56
Title
Time to Discontinuation Due to Lack of Efficacy
Description
Time to discontinuation due to lack of efficacy was defined as the time interval from the date of first study drug administration up to the date of discontinuation of participant from treatment due to lack of efficacy.
Time Frame
Baseline up to Week 56
Title
Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of participants with any use of rescue medication during the particular study week were summarized.
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Number of Participants Who Took Rescue Medication During Week 64
Description
In case of inadequate pain relief, after Week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of participants with any use of rescue medication during Week 64 were summarized.
Time Frame
Week 64
Title
Number of Days of Rescue Medication Used During Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Description
In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 3000 mg per day and up to 3 days in a week between baseline and Week 16, and 3000 mg per day and up to 7 days per week between Week 16 and 64 could be taken as rescue medication. Number of days the participants used the rescue medication during the particular study weeks were summarized.
Time Frame
Weeks 2, 4, 8, 16, 24, 32, 40, 48 and 56
Title
Number of Days of Rescue Medication Used During Week 64
Description
In case of inadequate pain relief, after week 16, acetaminophen/paracetamol up to 3000 mg per day up to 7 days in a week could be taken as rescue medication and use was reported weekly via diary. Number of days the participants used the rescue medication during Week 64 were summarized.
Time Frame
Week 64
Title
Amount of Rescue Medication Used During Weeks 2, 4, 8 and 16
Description
In case of inadequate pain relief, acetaminophen/paracetamol up to 3000 mg per day up to 3 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.
Time Frame
Weeks 2, 4, 8 and 16
Title
Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Visits of services directly related to OA evaluated were: visits to primary care physician, neurologist, rheumatologist, physician assistant or nurse practitioner, pain specialist, orthopedist, physical therapist, chiropractor, alternative medicine or therapy, podiatrist, nutritionist/dietitian, radiologist, home healthcare services and other practitioner.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who visited the emergency room due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis
Description
Osteoarthritis HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of visits to the emergency room due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who were hospitalized due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of nights stayed in the hospital due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who used any aids/devices for doing things. Aids such as walking aid, wheelchair, device or utensil for dress/bathe/eat and any other aids/devices.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was number of participants who quit job due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis
Description
OA HCRU assessed healthcare usage during the last 3 months (for Baseline and Week 80) and past 8 weeks (for Week 64). Domain evaluated was duration since quitting job due to OA.
Time Frame
Baseline, Weeks 64 and 80
Title
Number of Participants With Categorical Change From Baseline in Lower Extremity Activity Scale (LEAS) at Weeks 4, 8, 16, 24, 56 and 80
Description
The LEAS is a self-administered scale to assess activity level in participants having total knee arthroplasty. The LEAS scale reflected four levels of lower-extremity activity (1)housebound(unable to walk or a minimal ability to walk) (2)more ordinary walking about the house (3)walking about the community (4)walking about the community as well as substantial work or exercise. It consisted of 12 questions resulting in 18-level scale that allowed participants to select a single description that most represented his or her self-perceived activity level. The final score was simply the number of the descriptor selected by the participant as being most representative of his or her activity level. The minimum possible score was 1(entirely bedbound) and the maximum possible score was 18(currently competitive athlete). Higher score indicated increased activity. Categorical changes from baseline were reported in terms of improvement (Change >0), No change and worsening (Change less than [<] 0).
Time Frame
Baseline, Weeks 4, 8, 16, 24, 56 and 80
Title
Change From Baseline in Average Daily Minutes of Physical Activity at Weeks 16 and 56
Description
Participant activity level was assessed using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time Frame
Baseline, Weeks 16 and 56
Title
Change From Baseline in Average Daily Physical Activity Counts at Weeks 16 and 56
Description
An average daily physical activity count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time Frame
Baseline, Weeks 16 and 56
Title
Change From Baseline in Average Daily Minutes of Moderate to Vigorous Physical Activity at Weeks 16 and 56
Description
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - less than {<1500} counts moderate (1,500 - <6500 counts), and vigorous (>=6500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time Frame
Baseline, Weeks 16 and 56
Title
Change From Baseline in Average Daily Minutes of Bouted (Sustained) Moderate to Vigorous Physical Activity at Weeks 16 and 56
Description
An average daily physical activity count was measured using actigraphy which was then sorted into three intensity thresholds: light (100 - <1,500 counts) moderate (1,500 - <6,500 counts), and vigorous (>=6,500 counts). Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).A "bout" of moderate to vigorous activity was defined as 10 or more consecutive minutes above the moderate physical activity level threshold, with allowance for interruptions of 1 or 2 minutes below the threshold.
Time Frame
Baseline, Weeks 16 and 56
Title
Change From Baseline in Average Daily Step Count at Weeks 16 and 56
Description
Average daily step count was measured using actigraphy. Participants continuously wore the accelerometer (apart for water activities) in the morning until going to bed at night for 7 or 14 consecutive days while going about their usual daily activities. Participants maintained a log (electronic or written) to record when the accelerometer was put on in the morning and removed at night (or if removed for any other purpose).
Time Frame
Baseline, Weeks 16 and 56
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs.
Time Frame
Baseline up to Week 80
Title
Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 80 that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Time Frame
Baseline up to Week 80
Title
Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline
Description
Primary Abnormality criteria: HGB, hematocrit, RBC count <0.8* lower limit of normal(LLN); Ery. mean corpuscular volume/hemoglobin/ HGB concentration, RBCs distribution width <0.9*LLN, >1.1*upper limit of normal(ULN); platelets <0.5*LLN,>1.75*ULN; Leukocytes <0.6*LLN, >1.5*ULN; Lymphocytes, Neutrophils <0.8*LLN, >1.2*ULN; Basophils,Eosinophils,Monocytes>1.2*ULN; Prothrombin time/Intl. normalized ratio>1.1*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase,alanine aminotransferase,gamma GT,LDH,alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen,creatinine,Cholesterol,triglycerides >1.3*ULN; Urate>1.2*ULN; sodium<0.95*LLN,>1.05*ULN; potassium,chloride,calcium,magnesium,bicarbonate <0.9*LLN, >1.1*ULN; phosphate<0.8*LLN, >1.2*ULN; glucose<0.6*LLN, >1.5*ULN; HGB A1C >1.3*ULN; creatine kinase>2.0*ULN, specific gravity<1.003, >1.030; pH<4.5, >8;Urine erythrocytes,Leukocytes>=20.
Time Frame
Baseline up to Week 80
Title
Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline
Description
Primary Abnormality criteria: hemoglobin; hematocrit; RBC count < 0.8*LLN; Ery. mean corpuscular volume/ hemoglobin/ HGB concentration, erythrocytes distribution width <0.9*LLN, >1.1*ULN; platelets <0.5*LLN,>1.75*upper limit of normal (ULN); white blood cell count<0.6*LLN, >1.5*ULN; Lymphocytes, Lymphocytes/Leukocytes, Neutrophils, Neutrophils/Leukocytes <0.8*LLN, >1.2*ULN; Basophils, Eosinophils, Monocytes >1.2*ULN; total bilirubin>1.5*ULN; aspartate aminotransferase, alanine aminotransferase, gamma GT,LDH, alkaline phosphatase >3.0*ULN; total protein; albumin<0.8*LLN, >1.2*ULN; blood urea nitrogen, creatinine, Cholesterol, triglycerides >1.3*ULN; Urate >1.2*ULN; sodium <0.95*LLN,>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate <0.9*LLN, >1.1*ULN; phosphate <0.8*LLN, >1.2*ULN; glucose <0.6*LLN, >1.5*ULN; Hemoglobin A1C >1.3*ULN; creatine kinase >2.0*ULN; specific gravity<1.003, >1.030; Urine erythrocytes,Leukocytes>=20; Hyaline Casts>=1.
Time Frame
Baseline up to Week 80
Title
Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Description
Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Title
Change From Baseline in Heart Rate at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Description
Heart rate (pulse rate) was measured at sitting position.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Title
Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 56 and 80
Description
A 12-lead ECG was recorded after participants had rested for at least 5 minutes in the supine position in a quiet environment. All standard intervals (PR, QRS, QT, QTcF, QTcB, RR intervals) were collected. ECG abnormalities included: 1) QT interval, QT interval corrected using Bazett's formula (QTcB) and QT interval corrected using Fridericia's formula (QTcF): increase from baseline greater than (>) 30 millisecond (ms) or 60 ms; absolute value > 450 ms, >480 ms and > 500 ms; 2) heart rate (HR) : absolute value <=50 bpm and decrease from baseline >=20 bpm; absolute value >=120 beats per minute (bpm) and increase from baseline >=20 bpm; 3) PR interval: absolute value >=220 ms and increase from baseline >=20 ms; 4) QRS interval: absolute value >= 120 ms.
Time Frame
Baseline, Weeks 56 and 80
Title
Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 56 and 80
Description
Heart rate was measured at sitting position.
Time Frame
Baseline, Weeks 56 and 80
Title
Number of Participants With Confirmed Orthostatic Hypotension
Description
Orthostatic hypotension was defined as postural change (supine to standing) that met the following criteria: For systolic BP <=150 mmHg (mean supine): Reduction in systolic BP>=20 mmHg or reduction in diastolic BP>=10 mmHg at the 1 and/or 3 minute standing BP measurements. For systolic BP >150 mmHg (mean supine): Reduction in systolic BP>=30 mmHg or reduction in diastolic BP>=15 mmHg at the 1 and/or 3 minute standing BP measurements. If the 1 minute or 3 minute standing BP in a sequence met the orthostatic hypotension criteria, then that sequence was considered positive. If 2 of 2 or 2 of 3 sequences were positive, then orthostatic hypotension was considered confirmed.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Title
Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Weeks 24, 56 and 80
Description
The SAS is a 12 item (11 for females) questionnaire, from which the total number of symptoms (0-12 for males and 0-11 for females) is calculated. Each positive symptom is rated from 1 (not at all) to 5 (a lot). The total impact score was the sum of all symptom rating scores, with 0 assigned where the participant did not have the particular symptom. The range for the total impact score is 0-60 for males and 0-55 for females, higher scores indicating higher impact.
Time Frame
Baseline, Weeks 24, 56 and 80
Title
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Description
NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. NIS is the sum of scores of 37 items, from both the left and right side, where 24 items scored from 0 (normal) to 4 (paralysis), higher score indicated higher abnormality/impairment and 13 items scored from 0 (normal), 1 (decreased) and 2 (absent), higher score indicated higher impairment. NIS possible overall score ranged from 0 (no impairment) to 244 (maximum impairment), higher scores indicated increased impairment.
Time Frame
Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 80
Title
Number of Participants With Anti-Tanezumab Antibodies
Description
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA).
Time Frame
Baseline, Weeks 8, 16, 32, 48, 56, 64 and 80
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with Kellgren Lawrence X ray Grade of 2 as diagnosed by the Central Reader
Currently receiving a stable dose regimen of oral NSAID (naproxen, celecoxib, diclofenac, aceclofenac, loxoprofen, ibuprofen, meloxicam, nabumetone, sulindac or ketoprofen) as described in the protocol along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking acetaminophen and, tramadol or opioid treatments. Subjects must also maintain a stabilized, protocol specified NSAID dose regimen for at least the final 2 or 3 weeks of the Screening period
WOMAC Pain subscale score of at least 5 in the index knee or hip at Screening
Be willing to discontinue all non study pain medications for osteoarthritis and not use prohibited pain medications throughout the duration of the study
Female subjects of childbearing potential must agree to comply with protocol specified contraceptive requirements
Exclusion Criteria:
Subjects exceeding protocol defined BMI or body weight limits
History of other diseases specified in the protocol (eg, inflammatory joint diseases, crystalline diseases such as gout or pseudogout) that may involve the index joint and that could interfere with efficacy assessments
Radiographic evidence of protocol specified bone or joint conditions in any screening radiograph as determined by the central radiology reviewer
A history of osteonecrosis or osteoporotic fracture
History of significant trauma or surgery to a knee, hip or shoulder within the previous year
Planned surgical procedure during the duration of the study
Presence of conditions (eg, fibromyaliga, radiculopathy) associated with moderate to severe pain that may confound assessments or self evaluation of osteoarthritis pain
Signs or symptoms of carpal tunnel syndrome in the year prior to Screening
Considered unfit for surgery based upon American Society of Anesthesiologists physical classification system for surgery grading, or subjects who would not be willing to undergo joint replacement surgery if required
Contraindications to magnetic resonance imaging
History of intolerance or hypersensitivity to the oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated
History of intolerance or hypersensitivity to acetaminophen or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen is contraindicated
Use of prohibited medications without the appropriate washout period prior to Screening or Initial Pain Assessment Period
History of cancer within 5 years of Screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
Subjects with signs and symptoms of clinically significant cardiac disease as described in the protocol
Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities
History, diagnosis, or signs and symptoms of clinically significant neurological disease such as but not limited to peripheral or autonomic neuropathy
History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
History of known alcohol, analgesic or drug abuse within 2 years of Screening
Previous exposure to exogenous NGF or to an anti-NGF antibody
History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein
Poorly controlled hypertension as defined in the protocol or taking an antihypertensive that has not been stable for at least 1 month prior to Screening
Evidence of protocol defined orthostatic hypotension at Screening
Disqualifying score on the Survey of Autonomic Symptoms questionnaire at Screening
Screening AST, ALT, serum creatinine or HbA1c values that exceed protocol defined limits
Presence of drugs of abuse in screening urine toxicology panel
Positive hepatitis B, hepatitis C or HIV test results indicative of current infection
Participation in other investigational drug studies within protocol defined time limits
Pregnant, breastfeeding or female subjects of childbearing potential who are unwilling or unable to follow protocol required contraceptive requirements
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the investigator, would make the subject inappropriate for entry into this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Alabama Orthopaedic Surgeons
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Rheumatology Associates of North Alabama, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Ferguson Family Medicine
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85215
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Valley Pain Consultants
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Clinical Research Consortium
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Noble Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Quality of Life Medical & Research Centers, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Tucson Orthopaedic Institute - Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
CHI St. Vincent Medical Group Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Chrystal Johnson
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
KLR Business Group, Inc., dba Arkansas Clinical Research
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Larry Watkins, MD
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Lynn Institute of the Ozarks
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orange County Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Advanced Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
CITrials
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Osteoporosis Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Core Healthcare Group
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Pleitez Medical Clinic
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Triwest Research Associates, LLC
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
T. Joseph Raoof MD, INC/Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
San Diego Imaging Escondido
City
Escondido
State/Province
California
ZIP/Postal Code
92029
Country
United States
Facility Name
Med Investigations, Inc.
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628
Country
United States
Facility Name
Research Center of Fresno, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93702
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Allied Clinical Research
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
HealthCare Partners Clinical Research, LLC.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Marvel Clinical Research LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
BioSolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91941
Country
United States
Facility Name
eStudySite
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Arthritis & Osteoporosis Medical Center
City
La Palma
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center For United Research, Inc.
City
Lakewood
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Collaborative Neuroscience Network, LLC.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Aeon Research, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90010
Country
United States
Facility Name
American Institute of Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
InterMed Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
IMD Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Renaissance Imaging Medical Associates, Inc
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
NRC Research Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Advances in Medicine
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Probe Clinical Research Corporation
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
University of California, Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Clinical Trials Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Northern California Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Center for Clinical Trials of Sacramento, Inc.
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
San Diego Imaging, Kearny Mesa
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp and Children's MRI Center, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Artemis Institute for Clinical Research
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
CITrials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Syrentis Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Shariar Cohen, MD Corp.
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Westlake Medical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Bayview Research Group
City
Valley Village
State/Province
California
ZIP/Postal Code
91607
Country
United States
Facility Name
Renaissance Imaging Medical Associates, Inc
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Buhay & Maglunog MDS
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Prohealth Advanced Imaging
City
West Hills
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Advanced Rx Clinical Research Group, Inc
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Medvin Clinical Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Elite Clinical Trials
City
Wildomar
State/Province
California
ZIP/Postal Code
92595
Country
United States
Facility Name
Mountain View Clinical Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Mountain View Clinical Research, Inc
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
New England Research Associates, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Clinical Research Center of CT
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Delaware Arthritis
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Javed Rheumatology Associates, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
AARDS Research, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
RASF-Clinical Research, Inc
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Orthopedic Research Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Orthopaedic Associates of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Tampa Bay Medical Research, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Midland Florida Clinical Research Center, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
S&W Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Centre for Rheumatology, Immunology and Arthritis
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Clinical Physiology Associates
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
IMA
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
SIMEDHealth, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
South Florida Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Pines Clinical Research Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Care Partners Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32218
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Columbus Clinical Services LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Pharmax Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Clintex Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Larkin Imaging Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
M&M Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Quality Research & Medical Center LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
American Family Medical
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Sensible Healthcare, LLC.
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Journey Research, Inc.
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Sunshine Research Center
City
Opa-locka
State/Province
Florida
ZIP/Postal Code
33054
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Rheumatology Associates of Central Florida, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Omega Research Consultants, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Oviedo Medical Research, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Sacred Heart Orthopedics
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Orthopaedic Center of South Florida
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
St. Johns Center for Clinical Research
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Gulfcoast Research Institute, LLC
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Kennedy White Orthopaedic Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Precision Clinical Research, LLC.
City
Sunrise
State/Province
Florida
ZIP/Postal Code
33351
Country
United States
Facility Name
Phoenix Clinical Research, LLC.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
BayCare Medical Group, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Compass Research North LLC
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
Perimeter Institute for Clinical Research, Inc. DBA:/PICR Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Masters of Clinical Research, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
River Birch Research Alliance, LLC
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Arthritis Center of North Georgia
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Center for Advanced Research & Education
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Better Health Clinical Research, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Atlanta Orthopaedic Institute, LLC
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Herman Clinical Research, LLC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Idaho Sports Medicine Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Injury Care Research, LLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Institute Of Arthritis Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Chicago Clinical Research Institute Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Northwestern Memorial Hospital-Arkes Pavilion, Diagnostic Testing Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Affinity Clinical Research Institute
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Southwest Center for Healthy Joints, S.C.
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Methodist Research Administration Office
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
UnityPoint Clinic Rheumatology
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61636
Country
United States
Facility Name
OrthoIllinois
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
Quest Diagnostics
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61114
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Buynak Clinical Research, P.C.
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Mid-America Physiatrists, P.A.
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Phoenix Medical Research, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205-1138
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Otrimed Corporation
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Central Kentucky Research Associates, Inc.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Baton Rouge General Medical Center-Internal Medicine Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Baton Rouge General Medical Center-Midcity
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Baton Rouge General Medical Center-Bluebonnet
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Baton Rouge General Medical Center-Clinical Trials Office
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Centex Studies, Inc.
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Arthritis Treatment Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Beacon Clinical Research, LLC
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Great Lakes Research Group, Incorporated
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Onyx Clinical Research
City
Caro
State/Province
Michigan
ZIP/Postal Code
48723
Country
United States
Facility Name
Orthopaedic Associates of Michigan, PC
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
June D.O. PC
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Great Lakes Research Group
City
Pinconning
State/Province
Michigan
ZIP/Postal Code
48650
Country
United States
Facility Name
Michigan Orthopaedic Spine Surgeons
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Medical Research Associates Inc.
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49686
Country
United States
Facility Name
Oakland Medical Research Center
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Landmark Internal Medicine
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
University of Missouri Health Care-Investigational Pharmacy
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
University of Missouri School of Medicine- Clinical Research Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Advance Clinical Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Medex Healthcare Research, Inc.
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Physician Research Collaboration, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Affiliated Clinical Research, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Impact Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Office of Stephen H. Miller, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Office of Robert P. Kaplan, DO
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
G. Timothy Kelly, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
ActivMed Practices & Research, Inc.
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Ocean Rheumatology, PA
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Arthritis, Rheumatic and Back Disease Associates, PA
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Lovelace Scientific Resources Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
NYU Langone Ambulatory Care Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Drug Trials Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Drug Trials America
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center, Infusion Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Langone Arena Oncology, Laura and Issac Perlmutter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
NYU Langone Rheumatology Associates Long Island
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Lenox Hill Radiology
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Manhattan Medical Research Practice PLLC
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Upstate Clinical Research Associates, LLC
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Northstate Clinical Research, PLLC
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Wake Internal Medicine Consultants, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Plains Clinical Research Center, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Valley Medical Research/Valley Medical Primary Care
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Remington-Davis, Incorporated
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Optimed Research LTD
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Dayton Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
PriMed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Springboro Health Center
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
AC Clinical Research
City
Tiffin
State/Province
Ohio
ZIP/Postal Code
44883
Country
United States
Facility Name
Glendale Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Bone Joint & Spine Surgeons, Inc.
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Heritage Valley Medical Group, Inc.
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Clinical Trial Center LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Founders Research Corporation
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Clinical Research Center of Reading, LLC
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Main Street Physician's Care - Waterway
City
Little River
State/Province
South Carolina
ZIP/Postal Code
29566
Country
United States
Facility Name
Main Street Physician's Care - Loris
City
Loris
State/Province
South Carolina
ZIP/Postal Code
29569
Country
United States
Facility Name
North Myrtle Beach Family Practice
City
North Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29582
Country
United States
Facility Name
Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Physicians Quality Care
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
PMG Research, Inc. d/b/a PMG Research of Knoxville
City
Jefferson City
State/Province
Tennessee
ZIP/Postal Code
37760
Country
United States
Facility Name
PCET Research Center, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Diagnostic Imaging PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
ARC Clinical Research at Wilson Parke
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Urgent Care MD's
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Texas Orthopedic Specialists, PLLC
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Galenos Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Abigail R. Neiman, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Advances in Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mercury Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Centex Studies, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Memorial Pulmonology
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Facility Name
BI Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Clinical Investigations of Texas
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
ClinRX Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Quality Research, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Lee Medical Associates PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Progressive Clinical Research, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Panacea Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78228
Country
United States
Facility Name
Accurate Clinical Research Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Victorium Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States
Facility Name
DCT-Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
South Texas Radiology Imaging Centers
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Envision Imaging
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Oakbend Medical Center
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
ClinPoint Trials
City
Waxahachie
State/Province
Texas
ZIP/Postal Code
75165
Country
United States
Facility Name
Mercury Clinical Research
City
Webester
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Clinics of North Texas
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76302
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Granger Medical Clinic-Riverton
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Facility Name
Millennium Clinical Trials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22207
Country
United States
Facility Name
Charlottesville Medical Research Center, LLC
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Millennium Clinical Trials
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
National Clinical Research-Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Optimed Research, LTD
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Swedish Medical Center Investigational Drug Services Pharmacy
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Genesis Research Services
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Hunter Imaging Group
City
Cardiff
State/Province
New South Wales
ZIP/Postal Code
2285
Country
Australia
Facility Name
Optimus Clinical Research Pty Ltd
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Southern Radiology
City
Miranda
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Facility Name
Royal Hospital for Women
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Castlereagh Imaging
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Australian Clinical Research Network
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Spectrum Medical Imaging
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
AusTrials Pty Ltd
City
Sherwood
State/Province
Queensland
ZIP/Postal Code
4075
Country
Australia
Facility Name
CMAX Clinical Research Pty Ltd
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Adelaide Hospital Pharmacy
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Bensons Radiology
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Capital Radiology-Malvern
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Capital Radiology-Clayton
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
SKG Radiology Hollywood
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
RK Will Pty Ltd
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
CMIP-Centro Mineiro de Pesquisa LTDA
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
CCBR - Centro de Pesquisas e Analises Clinicas LTDA
City
Rio De Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Diagnostic Consultative Center "Sveti Georgi" EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Medical Center "Health for all" - EOOD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
UMHAT Kaspela - EOOD Rheumatology Clinic
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
UMHAT Kaspela - EOOD
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
"Medical Center Teodora" EOOD
City
Ruse
ZIP/Postal Code
7012
Country
Bulgaria
Facility Name
Diagnostic Consultative Center 17 Sofia EOOD
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
UMHAT Sveti Ivan Rilski- EAD
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
UMHAT "Sofiamed" OOD, Block 2
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Facility Name
"Medical Center- Dr. Hayvazov" EOOD
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Facility Name
Centro Integral de Reumatologia Reumalab S.A.S.
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
05001000
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas SAS CIREEM SAS
City
Bogota
State/Province
Bogota DC
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Medicinski centar Kuna&Peric
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
National Hospital Organization Toyohashi Medical Center
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
440-8510
Country
Japan
Facility Name
Funabashi Municipal Medical Center
City
Funabashi
State/Province
Chiba
ZIP/Postal Code
273-8588
Country
Japan
Facility Name
Matsudo City General Hospital
City
Matsudo
State/Province
Chiba
ZIP/Postal Code
270-2296
Country
Japan
Facility Name
Kanbara Clinic
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
806-0026
Country
Japan
Facility Name
Hidaka Orthopedic Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0053
Country
Japan
Facility Name
Obase Hospital
City
Miyako-gun
State/Province
Fukuoka
ZIP/Postal Code
800-0344
Country
Japan
Facility Name
Himeno Hospital
City
Yamegun
State/Province
Fukuoka
ZIP/Postal Code
834-0115
Country
Japan
Facility Name
Ikeda Kinen Hospital
City
Sukagawa
State/Province
Fukushima
ZIP/Postal Code
962-0001
Country
Japan
Facility Name
Zenshukai Hospital
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
379-2115
Country
Japan
Facility Name
Mazda Hospital
City
Aki-gun
State/Province
Hiroshima
ZIP/Postal Code
735-8585
Country
Japan
Facility Name
Medical Corporation Okimoto Clinic
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
734-0304
Country
Japan
Facility Name
Medical Corporation Emu Emukai, Matterhorn Rehabilitation Hospital
City
Kure
State/Province
Hiroshima
ZIP/Postal Code
737-0046
Country
Japan
Facility Name
Takahashi Orthopedics Clinic
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0062
Country
Japan
Facility Name
Obihiro Orthopaedic Hospital
City
Obihiro
State/Province
Hokkaido
ZIP/Postal Code
080-0802
Country
Japan
Facility Name
Okubo Hospital
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
674-0051
Country
Japan
Facility Name
Omuro Orthopedic Clinic
City
Himeji
State/Province
Hyogo
ZIP/Postal Code
670-0976
Country
Japan
Facility Name
Medical corporate corporation hoshikai Onishi medical clinic
City
Kako-gun
State/Province
Hyogo
ZIP/Postal Code
675-1115
Country
Japan
Facility Name
Kobe Red Cross Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
651-0073
Country
Japan
Facility Name
Mito Saiseikai General Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4198
Country
Japan
Facility Name
National Hospital Organization Kanazawa Medical Center
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8650
Country
Japan
Facility Name
Kokan Clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
Misugikai Medical Corporation Otokoyama Hospital
City
Yawata
State/Province
Kyoto
ZIP/Postal Code
614-8366
Country
Japan
Facility Name
Nakajo Orthopedic Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
983-0862
Country
Japan
Facility Name
Marunouchi Hospital
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8601
Country
Japan
Facility Name
Oita University Hospital
City
Yufu
State/Province
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
Sobajima Clinic/Orthopedics
City
Higashiosaka
State/Province
Osaka
ZIP/Postal Code
577-0011
Country
Japan
Facility Name
Rinku General Medical Center
City
Izumisano
State/Province
Osaka
ZIP/Postal Code
598-8577
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Social Welfare Organization Saiseikai Imperial Gift Foundation,Inc. Osaka Saiseikai Nakatsu Hospital
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Facility Name
Fujieda Municipal General Hospital
City
Fujieda
State/Province
Shizuoka
ZIP/Postal Code
426-8677
Country
Japan
Facility Name
JA Shizuoka Kohseiren Enshu Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-0929
Country
Japan
Facility Name
Japanese Red Cross Hamamatsu Hospital
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
434-8533
Country
Japan
Facility Name
Sonodakai Joint Replacement Center Hospital
City
Adachi-ku
State/Province
Tokyo
ZIP/Postal Code
121-0064
Country
Japan
Facility Name
Medical Plaza Edogawa
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
133-0052
Country
Japan
Facility Name
Sato Orthopaedic Clinic
City
Edogawa-ku
State/Province
Tokyo
ZIP/Postal Code
134-0084
Country
Japan
Facility Name
Fussa Hospital
City
Fussa
State/Province
Tokyo
ZIP/Postal Code
197-8511
Country
Japan
Facility Name
Jukoukai hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0073
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Tamagawa Hospital
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0095
Country
Japan
Facility Name
Kohno Clinical Medicine Research Institute Daisan Kitashinagawa Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0001
Country
Japan
Facility Name
Ohimachi Orthopaedic Clinic
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0014
Country
Japan
Facility Name
Japan Organization of Occupational Health and Safety Sanin Rosai Hospital
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8605
Country
Japan
Facility Name
National Hospital Organization Chiba Medical Center
City
Chiba
ZIP/Postal Code
260-8606
Country
Japan
Facility Name
Chihaya Hospital
City
Fukuoka
ZIP/Postal Code
813-8501
Country
Japan
Facility Name
Kuroda Orthopedic Hospital
City
Fukuoka
ZIP/Postal Code
814-0165
Country
Japan
Facility Name
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
City
Hiroshima
ZIP/Postal Code
730-8619
Country
Japan
Facility Name
Hiroshima Prefectural Hospital
City
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Facility Name
Kumamoto Orthopaedic Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Facility Name
Nagayoshi General Hospital
City
Osaka
ZIP/Postal Code
547-0016
Country
Japan
Facility Name
Iwasaki Orthopedic Surgery
City
Saitama
ZIP/Postal Code
330-0056
Country
Japan
Facility Name
Saitama Municipal Hospital
City
Saitama
ZIP/Postal Code
336-8522
Country
Japan
Facility Name
Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Division of Rheumatology, Department of Internal Medicine, Daegu Catholic University Medical Center
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Clinical Trial Center Pharmacy
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Pharmacy of Clinical Trial Center
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Clinical Trials Center Pharmacy
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Clinical Trial Center Pharmacy
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Clinical Research Pharmacy
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Department of Clinical Research Pharmacy, Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Division of Rheumatology, Department of Internal Medicine, Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Clinical Trial Center Pharmacy
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Department of Orthopedic Surgery, Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Clinical Research Pharmacy, SMG SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Department of Clinical Research Pharmacy, SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Department of Radiology
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy
City
Yangcheon-gu, Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Facility Name
Saules seimos medicinos centras
City
Kaunas
ZIP/Postal Code
LT-49449
Country
Lithuania
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Republican Siauliai Hospital
City
Siauliai
ZIP/Postal Code
LT-76231
Country
Lithuania
Facility Name
Centro Hospitalario Mac, S.A. de C.V.
City
Guadajara
State/Province
Jalisco
ZIP/Postal Code
45050
Country
Mexico
Facility Name
Consultorio Medico del Dr. Federico Galvan Villegas
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Lakeland Clinical Trials
City
Rotorua
State/Province
BOP
ZIP/Postal Code
3010
Country
New Zealand
Facility Name
Otago Radiology
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9010
Country
New Zealand
Facility Name
RMC Medical Research Ltd
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9012
Country
New Zealand
Facility Name
South Pacific Clinical Trials
City
Auckland
ZIP/Postal Code
0610
Country
New Zealand
Facility Name
TRG Imaging Lincoln Road
City
Auckland
ZIP/Postal Code
0610
Country
New Zealand
Facility Name
Auckland Bone Density Ltd
City
Auckland
ZIP/Postal Code
0612
Country
New Zealand
Facility Name
North Shore Hospital, Waitemata District Health Board
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Star Unit, North Shore Hospital, Waitemata District Health Board
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
The Radiology Group
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Southern Clinical Trials- Waitemata Ltd
City
Auckland
ZIP/Postal Code
0626
Country
New Zealand
Facility Name
Auckland Bone Density
City
Auckland
ZIP/Postal Code
0632
Country
New Zealand
Facility Name
Optimal Clinical Trials
City
Auckland
ZIP/Postal Code
1010
Country
New Zealand
Facility Name
Auckland Radiology Parnell Branch
City
Auckland
ZIP/Postal Code
1052
Country
New Zealand
Facility Name
Southern Clinical Trials Ltd
City
Christchurch
ZIP/Postal Code
8013
Country
New Zealand
Facility Name
Collingwood Street Pharmacy
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Nelson Radiology
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Porter Rheumatology Ltd
City
Nelson
ZIP/Postal Code
7010
Country
New Zealand
Facility Name
Bay Radiology
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
P3 Research Ltd
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Clinical Horizons NZ Ltd
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
P3 Research Ltd
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Pacific Radiology
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
City
Cayma
State/Province
Arequipa
Country
Peru
Facility Name
Centro De Investigacion Clinica Trujillo EIRL/Clinica Peruano Americana S.A.
City
Trujillo
State/Province
LA Libertad
ZIP/Postal Code
13001
Country
Peru
Facility Name
ABK REUMA S.R.L. de Medicentro Biociencias/BIO CIENCIAS PERU S.R.L.
City
Lima
ZIP/Postal Code
21
Country
Peru
Facility Name
Centro de Investigación Reumatología CAA-Clinica Anglo Americana
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Investigaciones en Reumatologia / Centro Medico Corpac S.A.
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Centro de Investigaciones Medicas-Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
29
Country
Peru
Facility Name
Investigaciones Clinicas S.A.C. / Instituto de Ginecologia y Reproduccion S.A.
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Investigaciones Clinicas S.A.C./Instituto de Ginecologia y Reproduccion S.A.
City
Lima
ZIP/Postal Code
33
Country
Peru
Facility Name
Philippine General Hospital
City
Manila
State/Province
NCR
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Manila Doctors Hospital
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Moscow Municipal Rheumatology Center
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
SBHI "City Clinical Hospital No. 1 n.a N.I. Pirogov"
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
SBHI "City Clinical Hospital No. 1 n.a. N.I. Pirogov"
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Research institution of fundamental and clinical immunology
City
Novosibirsk
ZIP/Postal Code
630047
Country
Russian Federation
Facility Name
Federal State Budgetary Scientific Institution
City
Novosibirsk
ZIP/Postal Code
630117
Country
Russian Federation
Facility Name
State Budgetary Institution of Ryazan Region
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Medical Technologies Ltd
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
Limited Liability Company "Medical Center "Reavita Med SPb"
City
Saint Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Medinet LLC
City
Saint Petersburg
ZIP/Postal Code
194356
Country
Russian Federation
Facility Name
FSBI 'SRITO n.a. R.R. Vreden' MoH RF
City
Saint Petersburg
ZIP/Postal Code
195427
Country
Russian Federation
Facility Name
Institute for Rehabilitation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute of Rheumatology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Institute for treatment and rehabilitation "Niska Banja"
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Special Hospital for Rheumatic Diseases Novi Sad
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
General hospital "Dr Laza K. Lazarevic" Sabac
City
Sabac
ZIP/Postal Code
15000
Country
Serbia
Facility Name
Reumatologia s.r.o.
City
Bratislava
ZIP/Postal Code
820 07
Country
Slovakia
Facility Name
Nestatna Reumatologicka Ambulancia, Poliklinika Karlova Ves
City
Bratislava
ZIP/Postal Code
841 04
Country
Slovakia
Facility Name
MUDr. STRANAI s.r.o.
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Reum.hapi s.r.o.
City
Nove Mesto nad Vahom
ZIP/Postal Code
91501
Country
Slovakia
Facility Name
MEDIPA s.r.o.
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Thermium s.r.o.
City
Piestany
ZIP/Postal Code
92101
Country
Slovakia
Facility Name
Changhua Christian Hospital Clinical Trial Pharmacy
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-Kaohsiung Branch Clinical Trial Pharmacy
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-Kaohsiung Branch
City
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital Clinical Trial Pharmacy
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Department of Pharmacy, China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Regional Communal Institution Chernivtsi Regional Clinical Hospital
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Communal Non-profit Institution "City Clinical Hospital No.27" of Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Government Institution "L.T. Malaya Therapy National Institute of the NAMS of Ukraine"
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Chair of Internal Medicine #2
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Oleksandrivska Clinical Hospital Of Kyiv
City
Kyiv
ZIP/Postal Code
01601
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital 3,Rheumatology Department
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Clinic of NI "NSC"M.D.Strazhesko Institute of Cardiology" of NAMS of Ukraine,
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Facility Name
Polyclinic of Administration of Medical Services and Rehabilitation of State Stock Holding Company
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Clinic of SI "Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine"
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Clinic of SI Institute of Gerontology named after D.F Chebotarov of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
National Medical University named after O O Bogomolets,
City
Kyiv
ZIP/Postal Code
04119
Country
Ukraine
Facility Name
Polyclinic Of Administration of Medical Services and Rehabilitation of SSHC Artem
City
Kyiv
ZIP/Postal Code
04119
Country
Ukraine
Facility Name
Communal Non-profit Institution "City Clinical Hospital #5 of Lviv", Therapeutics Department
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Communal Institution "Odesa Regional Clinical Hospital"
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Multi-field Medical Center (University Clinic No.1) of Odesa National Medical University,
City
Odesa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Communal Institution Ternopil University Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov, Rheumatology Department,
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Communal Non-commercial Enterprise "Vinnytsia City Clinical Hospital No 1"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Medical Clinical Investigational Centre of Medical Centre Health Clinic LTD
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Scientific and Research Institute of Invalid Rehabilitation (Educational and Scientific Medical
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Vinnytsya Medical National University named after M.I. Pyrogov, Chair of Internal Medicine #3
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Communal Institution Zaporizhzhya Regional Clinical Hospital
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
36301512
Citation
Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2023 Jan;40(1):252-264. doi: 10.1007/s12325-022-02336-6. Epub 2022 Oct 27.
Results Reference
derived
PubMed Identifier
35980115
Citation
Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Nov;38(11):1909-1922. doi: 10.1080/03007995.2022.2113689. Epub 2022 Aug 28.
Results Reference
derived
PubMed Identifier
35960482
Citation
Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.
Results Reference
derived
PubMed Identifier
35351194
Citation
Neogi T, Hunter DJ, Churchill M, Shirinsky I, White A, Guermazi A, Omata M, Fountaine RJ, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Observed efficacy and clinically important improvements in participants with osteoarthritis treated with subcutaneous tanezumab: results from a 56-week randomized NSAID-controlled study. Arthritis Res Ther. 2022 Mar 29;24(1):78. doi: 10.1186/s13075-022-02759-0.
Results Reference
derived
PubMed Identifier
35232805
Citation
Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.
Results Reference
derived
PubMed Identifier
35217440
Citation
Brown MT, Sandroni P, Low PA, Gorson KC, Hunter DJ, Pixton GC, Fountaine RJ, Viktrup L, West CR, Verburg KM. Neurological safety of subcutaneous tanezumab versus NSAID in patients with osteoarthritis. J Neurol Sci. 2022 Mar 15;434:120184. doi: 10.1016/j.jns.2022.120184. Epub 2022 Feb 14.
Results Reference
derived
PubMed Identifier
33538113
Citation
Hochberg MC, Carrino JA, Schnitzer TJ, Guermazi A, Walsh DA, White A, Nakajo S, Fountaine RJ, Hickman A, Pixton G, Viktrup L, Brown MT, West CR, Verburg KM. Long-Term Safety and Efficacy of Subcutaneous Tanezumab Versus Nonsteroidal Antiinflammatory Drugs for Hip or Knee Osteoarthritis: A Randomized Trial. Arthritis Rheumatol. 2021 Jul;73(7):1167-1177. doi: 10.1002/art.41674. Epub 2021 Jun 7.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091058&StudyName=A%20Phase%203%20Randomized%2C%20Double-blind%2C%20Active-controlled%2C%20Multicenter%20Study%20Of%20The%20Long-term%20Safety%20And%20Efficacy%20Of%20Subcutaneous%20Administration%20Of%20Tanezumab%20In%20Subjects%20With%20Osteoarthritis%20Of%20The%20Hip%20Or%20Knee
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Long Term Safety and Efficacy Study of Tanezumab in Subjects With Osteoarthritis of the Hip or Knee
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