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Extension Study Of Tanezumab In Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tanezumab
tanezumab
tanezumab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Tanezumab OA arthritis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

  • Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator

Sites / Locations

  • Pinncale Research Group, LLC
  • Anniston Medical Clinic, PC
  • Pinnacle Research Group, LLC
  • Greystone Medical Center
  • Saadat Ansari, MD Office
  • Coastal Clinical Research, Inc.
  • Horizon Research Group
  • Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
  • Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC
  • Novara Clinical Research
  • Clinical Research Advantage, Inc.
  • Arizona Arthritis & Rheumatology Research, PLLC
  • Pivotal Research Center
  • Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC
  • Arizona Research Center
  • Clinical Research Advantage, Inc.
  • Arizona Arthritis & Rheumatology Associates, P.C.
  • Paradigm Clinical, Inc.
  • Quality of Life Medical & Research Center, LLC
  • Quality of Life Medical and Research Center
  • Tucson Orthopaedic Institute
  • University of Arizona
  • St. Joseph's Mercy Clinic
  • Osteoporosis Medical Center
  • Providence Clinical Research
  • eStudySite
  • Colorado Hematology - Oncology
  • Colorado Orthopedic Consultants, PC
  • Arthritis Medical Clinic of North County, Inc.
  • Edinger Medical Group Clinical Research
  • Valley Research
  • Talbert Medical Group
  • Lakewood Orthopedic Medical & Surgical Group
  • High Desert Medical Group Research for Life
  • Premiere Clinical Research, LLC
  • Samaritan Center for Medical Research
  • Del Carmen Medical Center
  • Probe Clinical Research, Corp.
  • Trinity Clinical Trials
  • Office of Lawrence P McAdam, MD
  • Westlake Medical Research
  • Colorado Orthopedic Consultants, PC
  • Peak Anesthesia and Pain Management
  • Denver Internal Medicine Group
  • Mountain View Clinical Research, Inc.
  • Advanced Orthopedic and Sports Medicine
  • American Clinical Research, LLC
  • Orthopaedic Physicians Of Colorado, P.C.
  • University Parks Hematology/Oncology
  • Advanced Orthopedic and Sports Medicine
  • Clinical Research Center of Connecticut
  • Norwalk Medical Group
  • Stamford Therapeutics Consortium
  • Delaware Arthritis
  • Javed Rheumatology Associates, Inc.
  • HeartCare (Private Practice)
  • Innovative Research of West Florida, Inc.
  • Tampa Bay Medical Research, Inc.
  • Clinical Research of South Florida
  • Avail Clinical Research, LLC
  • Arthritis Associates of South Florida
  • Delray Research Associates
  • In Vivo Clinical Research, Inc
  • S & W Clinical Research
  • Centre for Rheumatology, Immunology and Arthritis
  • Westside Center for Clinical Research
  • Adult Medicine Specialists
  • Genesis Research International
  • Pharmax Research Clinic, Inc
  • Kendall South Medical Center, Inc.
  • Sunshine Research Center
  • Compass Research, LLC
  • Rheumatology Associates of Central Florida
  • The Arthritis Center
  • University Clinical Research Incorporated
  • Advent Clinical Research Centers, Inc.
  • Progressive Medical Research
  • Dale G. Bramlet, MD, P.L.
  • HeartCare Research
  • West Broward Rheumatology Associates, Inc.
  • Tampa Medical Group, PA
  • Palm Beach Research Center
  • Laureate Clinical Research Group
  • Arthritis and Rheumatology of Georgia
  • Laureate Clinical Research Group
  • Masters of Clinical Research, Inc.
  • River Birch Research Alliance, LLC
  • Jefrey D. Lieberman, MD
  • Early Family Practice Center
  • Northeast Georgia Diagnostic Clinic, LLC
  • Marietta Rheumatology Associates
  • North Georgia Clinical Research
  • North Georgia Internal Medicine
  • Sonora Clinical Research, LLC.
  • Millennium Pain Center
  • Rehabilitation Institute of Chicago
  • Illinois Bone and Joint Institute, LLC
  • Koch Family Medicine
  • The Arthritis Center
  • MediSphere Medical Research Center, LLC
  • American Health Network
  • Memorial Medical Group Clinical Research Institute
  • Northwest Indiana Center for Clinical Research
  • McFarland Clinic, PC
  • Integrated Clinical Trial Services, Inc.
  • Professional Research Network of Kansas, LLC
  • Pasadena Pharmacy
  • The Pain Treatment Center of the Bluegrass
  • Arthritis Center of Lexington
  • Bluegrass Community Research, Inc
  • David H. Neustadt, MD
  • L-Marc Research Center
  • Bone and Joint Clinic of Baton Rouge
  • Gulf Coast Research, LLC
  • The Baton Rouge Clinic
  • Stanocola Medical Center
  • Arthritis and Diabetes Clinic
  • Maine Research Associates
  • Arthritis Treatment Center
  • Mid-Atlantic Medical Research Centers
  • The Center for Rheumatology and Bone Research
  • Beacon Clinical Research, LLC
  • Miray Medical Center
  • Mansfield Health Center
  • Arthritis Associates Inc.
  • Clinical Pharmacology Study Group
  • Ann Arbor Clinical Research
  • Great Lakes Research Group, Incorporated
  • KMED Research
  • MAPS Applied Research Center Inc.
  • Medical Advanced Pain Specialists
  • Planters Clinic
  • Medex Healthcare Research
  • Mercy Health Research
  • St. John's Clinic - Neurology
  • St. John's Medical Research Institute, Inc.
  • Midwest Minor Medical
  • Quality Clinical Research, Inc.
  • Midwest Minor Medical
  • Midwest Minor Medical
  • Diagnostic Center of Medicine
  • Independent Clinical Researchers
  • Wolfson Medical Center
  • Clinical Research Consortium
  • Mirkil Medical
  • G. Timothy Kelly, MD
  • Office of Dr. Danka Michaels, MD
  • Comprehensive Clinical Research
  • Albuquerque Clinical Trials
  • New Mexico Clinical Research & Osteoporosis Center, Incorporated
  • SPRI Bronx LLC
  • Arthritis and Osteoporosis Medical Associates
  • Medex Healthcare Research
  • The Medical Research Network, LLC
  • Prem C. Chatpar, MD, LLC
  • AAIR Research Center
  • Office of Dr. Andrew Porges
  • Arthritis and Osteoporosis Consultants of the Carolinas
  • Carolina Bone & Joint, PA
  • Pharmquest
  • PMG Research of Winston-Salem
  • Odyssey Research
  • Plains Medical Clinic, LLC
  • Consultants for Clinical Research Incorporated
  • Ohio GI and Liver Institute
  • Hilltop Medical Research Center
  • Columbus Clinical Research, Inc.
  • PHP Center for Clinical Research
  • Paramount Medical Research and Consulting, LLC
  • Orthopaedic & Sports Medicine Consultants
  • Signal Point Clinical Research Center
  • Pharmacotherapy Research Associates,Inc
  • Physicians' Research, Inc
  • Primecare of Southeastern Ohio, Inc
  • Cor Clinical Research, LLC
  • Health Research Institute
  • East Penn Rheumatology Associates, PC
  • Brandywine Clinical Research
  • Altoona Center for Clinical Research
  • Clinical Research Center of Reading, LLP
  • Low Country Rheumatology, PA
  • The Family Healthcare Center, PA
  • Southern Orthopaedic Sports Medicine
  • Coastal Carolina Research Center
  • The Carolina Center for Rheumatology and Arthritis Care, PA
  • Health Concepts
  • State of Franklin Healthcare Associates, PLLC
  • Holston Medical Group
  • Capitol Medical Clinic
  • Walter F. Chase, MD, PA
  • Tekton Research, Inc.
  • North Texas Joint Care, PA
  • Crown Imaging
  • Metroplex Clinical Research Center
  • Radiant Research
  • O. David Taunton, Jr, MD
  • Asif Cochinwala, MD, PA
  • Foundation for Southwest Orthopedic Research
  • One Step Diagnostic
  • Southwest Orthopedic Group
  • The Neurology Center
  • Pioneer Research Solutions, Inc.
  • Gill Orthopedic Center
  • Robert R. King, M.D.
  • Clinical Investigations of Texas, LLC
  • Radiant Research San Antonio Northeast
  • Texas Arthritis Research Center, PA
  • Diagnostics Research Group
  • Spring Family Practice Associates PA
  • AZ Clinical Research
  • Spring Clinical Research
  • Sugar Land Med-Ped, P.A.
  • Grayline Clinical Drug Trials
  • Aspen Clinical Research
  • Foothill Family Clinic
  • J. Lewis Research, Incorporated/Foothill Family Clinic South
  • Commonwealth Orthopaedics and Rehabilitation, PC
  • IntegraTrials, LLC
  • Virginia Hospital Center
  • Charlottesville Medical Research
  • National Clinical Research - Norfolk, Inc.
  • Office of Doris M. Rice, MD, FACR
  • HhypotheTest, LLC
  • Empirical Clinical Trials
  • Arthritis Northwest
  • Clinical Trials Northwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tanezumab 10 mg

Tanezumab 5 mg

Tanezumab 2.5 mg

Arm Description

Tanezumab 10 mg

Tanezumab 5 mg

Tanezumab 2.5 mg

Outcomes

Primary Outcome Measures

Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of 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 are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Number of Participants With Abnormal Laboratory Findings
Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.

Secondary Outcome Measures

Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.
Number of Participants With Clinically Significant Abnormality in Vital Signs
Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 1)WOMAC pain subscale, 2)WOMAC physical function subscale, 3)PGA of osteoarthritis (score: 1-5, higher score=more affected).WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score:0-10, higher score=higher pain/difficulty).
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Percentage of Participants Who Used Concomitant Analgesic Medication
United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.
Days Per Week of Concomitant Analgesic Medication Usage
FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.

Full Information

First Posted
December 16, 2008
Last Updated
April 14, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00809783
Brief Title
Extension Study Of Tanezumab In Osteoarthritis
Official Title
A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
February 6, 2009 (Actual)
Primary Completion Date
November 2, 2010 (Actual)
Study Completion Date
June 23, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
Detailed Description
This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Tanezumab OA arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tanezumab 10 mg
Arm Type
Experimental
Arm Description
Tanezumab 10 mg
Arm Title
Tanezumab 5 mg
Arm Type
Experimental
Arm Description
Tanezumab 5 mg
Arm Title
Tanezumab 2.5 mg
Arm Type
Experimental
Arm Description
Tanezumab 2.5 mg
Intervention Type
Biological
Intervention Name(s)
tanezumab
Other Intervention Name(s)
RN624
Intervention Description
Tanezumab 10 mg
Intervention Type
Biological
Intervention Name(s)
tanezumab
Other Intervention Name(s)
RN624
Intervention Description
Tanezumab 5 mg
Intervention Type
Biological
Intervention Name(s)
tanezumab
Other Intervention Name(s)
RN624
Intervention Description
Tanezumab 2.5 mg
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Description
AE:any untoward medical occurrence in participant who received study medication without regard to possibility of causal relationship. SAE:an AE resulting in any of 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 are events between first dose of study medication and up to 112 days after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Time Frame
A4091016: Baseline (Day 1) up to 112 days after last dose of study medication (up to Week 80)
Title
Number of Participants With Abnormal Laboratory Findings
Description
Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN),MCV,MCH,MCHC<0.9*LLN or >1.1*ULN,platelet:<0.5*LLN or >1.75*upper limit of normal(ULN),white blood cell(WBC):<0.6*LLN or >1.5*ULN,lymphocyte,neutrophil,total neutrophil:<0.8*LLN or>1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN;total,direct bilirubin>1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,LDH,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;cholesterol,triglycerides>1.3*ULN;sodium <0.95*LLN or >1.05*ULN,potassium,chloride,calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN,phosphate<0.8*LLN or>1.2*ULN;glucose <0.6*LLN or >1.5*ULN,glycosylated Hgb >1.3*ULN,creatine kinase>2.0*ULN;urine(specific gravity <1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >1.5*ULN,epithelial cell>=6,casts,hyaline cast>1,bacteria>20).
Time Frame
A4091016: Day 1 up to Week 80
Title
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Findings
Description
Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and VR interval. Number of participants with clinically significant abnormal ECG findings were judged by investigator and reported as adverse events were presented.
Time Frame
A4091016: Baseline (Day 1) up to Week 80
Secondary Outcome Measure Information:
Title
Change From Parent Study Baseline in Neuropathy Impairment Score (NIS) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72
Description
NIS constitutes sum of 37 standard items of neuromuscular examination used to assess muscle strength, reflexes and sensation. Each item is scored separately for left and right sides. Components of muscle weakness (24 items) scored on a scale: 0 (normal) to 4 (paralysis), with higher score=more weakness; components of reflexes and sensation (13 items) scored on a scale: 0= normal, 1= decreased or 2= absent. Total NIS score range 0 (no impairment) to 244 (maximum impairment), higher score = more impairment. Parent study baseline value calculated as average of pre-dose measurements of participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72
Title
Number of Participants With Anti-drug Antibodies (ADA) for Tanezumab
Description
Human serum anti-drug antibody (ADA) samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA). Same participant may have positive ADA result at more than 1 time point.
Time Frame
A4091016: Day 1, Week 16, 24, 40, 56, 72, 80 or Early Termination (ET: anytime till Week 80)
Title
Number of Participants With Clinically Significant Changes From Baseline to Week 80 in Physical Examination Findings
Description
Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat and thyroid. Clinically significant changes were judged by investigator.
Time Frame
Baseline (Day 1) up to Week 80
Title
Number of Participants With Clinically Significant Abnormality in Vital Signs
Description
Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, heart rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs were judged by investigator and reported as adverse events were presented.
Time Frame
A4091016: Baseline (Day 1) up to Week 80
Title
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC physical function score is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate worse function. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicate worse condition. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Description
OMERACT-OARSI response:>=50 percent(%) improvement from parent study baseline and absolute change from parent study baseline of >=2 units at given week in WOMAC pain or physical function subscale or >=20% improvement from parent study baseline and absolute change from parent study baseline of >=1 unit at given week in at least 2 of following 3 items: 1)WOMAC pain subscale, 2)WOMAC physical function subscale, 3)PGA of osteoarthritis (score: 1-5, higher score=more affected).WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score:0-10, higher score=higher pain/difficulty).
Time Frame
A4091016: Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96, 104
Title
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Parent Study Baseline in WOMAC Pain Subscale Score
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Number of Participants With Cumulative Reduction From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16, 24, 56 and 104
Description
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip joint during past 48 hours. The WOMAC pain score is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (minimum pain) to 10 (maximum pain), where higher scores indicate higher pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 16, 24, 56, 104
Title
Percentage of Participants With Improvement of at Least 2 Points From Parent Study Baseline in Patient Global Assessment (PGA) of Osteoarthritis
Description
Participants answered: "Considering all the ways your osteoarthritis in your knee/hip affects you, how are you doing today?" Participants responded by using a 5-point scale where 1 = very good and 5 = very poor. Higher scores indicated worse pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
WOMAC stiffness subscale: questionnaire used to assess amount of stiffness experienced due to osteoarthritis in index joint during past 48 hours. The WOMAC stiffness score is calculated as mean of scores from 2 individual questions scored on NRS of 0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score =0 (minimum stiffness) to 10 (maximum stiffness), higher scores indicate higher stiffness. Stiffness is defined as sensation of decreased ease in movement of knee/hip. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of knee or hip. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (minimum difficulty) to 10 (maximum difficulty), where higher score indicates worse response. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Going Up or Downstairs at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
Participants answered: "How much pain have you had going up or down the stairs?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Change From Parent Study Baseline For Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item: Pain When Walking on a Flat Surface at Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, 96 and 104
Description
Participants answered: "How much pain have you had when walking on a flat surface?" Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = extreme pain. Higher score indicates more pain. Parent study baseline value calculated as average of pre-dose measurements of the participants from study A4091011, A4091014, A4091015 and A4091018.
Time Frame
Baseline of the parent study (A4091011, A4091014, A4091015, A4091018); A4091016: Week 4, 8, 16, 24, 32, 40, 48,56, 64, 72, 80, 88, 96, 104
Title
Percentage of Participants Who Used Concomitant Analgesic Medication
Description
United States Food and Drug Administration (FDA) approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, non-steroidal anti inflammatory drugs (NSAIDs), capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed as per investigator's discretion.
Time Frame
Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
Title
Days Per Week of Concomitant Analgesic Medication Usage
Description
FDA approved analgesics (over-the-counter or prescription) were permitted as concomitant medications to relieve the pain of osteoarthritis. These medications included opioids, topical analgesics, NSAIDs, capsaicin products, oral/injectable corticosteroids and viscosupplementation (hyaluronan) and were prescribed at the discretion of the investigator.
Time Frame
Week 1-4, 5-8, 9-16, 17-24, 25-32, 33-40, 41-48, 49-56, 57-64, 65-72, 73-80, 81-88, 89-96, 97-104, 105-112
Other Pre-specified Outcome Measures:
Title
Number of Participants Classified According to Number of Intravenous Doses of Study Medication
Description
Number of participants were reported based on the maximum number of intravenous doses of either tanezumab or placebo received.
Time Frame
A4091016: Baseline (Day 1) up to Week 64

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis Exclusion Criteria: Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
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
Pinncale Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36201
Country
United States
Facility Name
Anniston Medical Clinic, PC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Greystone Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Saadat Ansari, MD Office
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
Horizon Research Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Clinical Research Advantage, Inc./Mesa Family Medical Center, PC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
Facility Name
Clinical Research Advantage, Inc./Central Arizona Medical Associates, PC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Novara Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Clincial Research Advantage, Inc/Central Phoenix Medical Clinic, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Clinical Research Advantage, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, P.C.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Paradigm Clinical, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Quality of Life Medical and Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
St. Joseph's Mercy Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Osteoporosis Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
eStudySite
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Colorado Hematology - Oncology
City
Englewood
State/Province
California
ZIP/Postal Code
80110
Country
United States
Facility Name
Colorado Orthopedic Consultants, PC
City
Englewood
State/Province
California
ZIP/Postal Code
80110
Country
United States
Facility Name
Arthritis Medical Clinic of North County, Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Edinger Medical Group Clinical Research
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Valley Research
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Lakewood Orthopedic Medical & Surgical Group
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
High Desert Medical Group Research for Life
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Premiere Clinical Research, LLC
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Facility Name
Samaritan Center for Medical Research
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Del Carmen Medical Center
City
Reseda
State/Province
California
ZIP/Postal Code
91335
Country
United States
Facility Name
Probe Clinical Research, Corp.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Trinity Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Office of Lawrence P McAdam, MD
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Colorado Orthopedic Consultants, PC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Peak Anesthesia and Pain Management
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Denver Internal Medicine Group
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
Advanced Orthopedic and Sports Medicine
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
American Clinical Research, LLC
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Orthopaedic Physicians Of Colorado, P.C.
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University Parks Hematology/Oncology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Advanced Orthopedic and Sports Medicine
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Clinical Research Center of Connecticut
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Norwalk Medical Group
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06851
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
HeartCare (Private Practice)
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34202
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
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
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
In Vivo Clinical Research, Inc
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
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
33334
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Adult Medicine Specialists
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Genesis Research International
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Pharmax Research Clinic, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Kendall South Medical Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Sunshine Research Center
City
Opa-locka
State/Province
Florida
ZIP/Postal Code
33054-3818
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
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
University Clinical Research Incorporated
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Advent Clinical Research Centers, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Dale G. Bramlet, MD, P.L.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
HeartCare Research
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
West Broward Rheumatology Associates, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Tampa Medical Group, PA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
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
Laureate Clinical Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Arthritis and Rheumatology of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Laureate Clinical Research Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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
Jefrey D. Lieberman, MD
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Early Family Practice Center
City
Fort Valley
State/Province
Georgia
ZIP/Postal Code
31030
Country
United States
Facility Name
Northeast Georgia Diagnostic Clinic, LLC
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Marietta Rheumatology Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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
Sonora Clinical Research, LLC.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Millennium Pain Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Illinois Bone and Joint Institute, LLC
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Koch Family Medicine
City
Morton
State/Province
Illinois
ZIP/Postal Code
61550
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
American Health Network
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46038
Country
United States
Facility Name
Memorial Medical Group Clinical Research Institute
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Northwest Indiana Center for Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
McFarland Clinic, PC
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Integrated Clinical Trial Services, Inc.
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Professional Research Network of Kansas, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Pasadena Pharmacy
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
The Pain Treatment Center of the Bluegrass
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Arthritis Center of Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Bluegrass Community Research, Inc
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
Facility Name
David H. Neustadt, MD
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
L-Marc Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Bone and Joint Clinic of Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Gulf Coast Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
The Baton Rouge Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Stanocola Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70816
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Arthritis Treatment Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Mid-Atlantic Medical Research Centers
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
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
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Mansfield Health Center
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Arthritis Associates Inc.
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Ann Arbor Clinical Research
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
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
KMED Research
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Facility Name
MAPS Applied Research Center Inc.
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Medical Advanced Pain Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Planters Clinic
City
Port Gibson
State/Province
Mississippi
ZIP/Postal Code
39150
Country
United States
Facility Name
Medex Healthcare Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. John's Clinic - Neurology
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
St. John's Medical Research Institute, Inc.
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68127
Country
United States
Facility Name
Midwest Minor Medical
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Facility Name
Diagnostic Center of Medicine
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Independent Clinical Researchers
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Wolfson Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89103
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Mirkil Medical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
G. Timothy Kelly, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Office of Dr. Danka Michaels, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Incorporated
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
SPRI Bronx LLC
City
Bronx
State/Province
New York
ZIP/Postal Code
10454
Country
United States
Facility Name
Arthritis and Osteoporosis Medical Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Medex Healthcare Research
City
New York
State/Province
New York
ZIP/Postal Code
10022
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
Prem C. Chatpar, MD, LLC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Office of Dr. Andrew Porges
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576-1507
Country
United States
Facility Name
Arthritis and Osteoporosis Consultants of the Carolinas
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207-1198
Country
United States
Facility Name
Carolina Bone & Joint, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pharmquest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Odyssey Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Plains Medical Clinic, LLC
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Consultants for Clinical Research Incorporated
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio GI and Liver Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hilltop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Columbus Clinical Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
PHP Center for Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Paramount Medical Research and Consulting, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Orthopaedic & Sports Medicine Consultants
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Signal Point Clinical Research Center
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Pharmacotherapy Research Associates,Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Physicians' Research, Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Primecare of Southeastern Ohio, Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Cor Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
East Penn Rheumatology Associates, PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015-1153
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335-2620
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
The Family Healthcare Center, PA
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
Facility Name
Southern Orthopaedic Sports Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
The Carolina Center for Rheumatology and Arthritis Care, PA
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
State of Franklin Healthcare Associates, PLLC
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Capitol Medical Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Walter F. Chase, MD, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Tekton Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
North Texas Joint Care, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Crown Imaging
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
O. David Taunton, Jr, MD
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Asif Cochinwala, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Foundation for Southwest Orthopedic Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
One Step Diagnostic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Southwest Orthopedic Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Neurology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pioneer Research Solutions, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Gill Orthopedic Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Robert R. King, M.D.
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Clinical Investigations of Texas, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Radiant Research San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Arthritis Research Center, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Spring Family Practice Associates PA
City
Spring
State/Province
Texas
ZIP/Postal Code
77379
Country
United States
Facility Name
AZ Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Spring Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Sugar Land Med-Ped, P.A.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Incorporated/Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Commonwealth Orthopaedics and Rehabilitation, PC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
IntegraTrials, LLC
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Virginia Hospital Center
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Office of Doris M. Rice, MD, FACR
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23701
Country
United States
Facility Name
HhypotheTest, LLC
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24018
Country
United States
Facility Name
Empirical Clinical Trials
City
Selah
State/Province
Washington
ZIP/Postal Code
98942
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2336
Country
United States
Facility Name
Clinical Trials Northwest
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

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
26554876
Citation
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091016&StudyName=Extension%20Study%20Of%20Tanezumab%20In%20Osteoarthritis
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Extension Study Of Tanezumab In Osteoarthritis

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