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Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tanezumab

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Osteoarthritis, pain, tanezumab.

Eligibility Criteria

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

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 at least 2 as diagnosed by the Central Reader
A history of insufficient pain relief from acetaminophen along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking NSAIDs, and tramadol or opioid treatments.
WOMAC Pain subscale score of at least 5 in the index hip or knee 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 (e.g. 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 (e.g. fibromyalgia, 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.
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

Nuhr Medical Center
Rheuma Zentrum Favoriten
Medical Center BLAGOEVGRAD 2009, EOOD
DCC St. Pantaleimon OOD
Medical Center " Health for all" EOOD
UMHAT Kaspela
"Medical Center Teodora" EOOD
Multiprofile Hospital for Active Treatment-Silistra AD
"Medical Center- Smolyan" OOD
NMTH 'Tsar Boris III". Clinic of Internal Diseases
Multiprofile hospital for active treatment - "Lyulin" EAD
Diagnostic Consultative Center XIV- Sofia EOOD
Medical Center-Avicena EOOD
UMHAT Sveti Ivan Rilski - EAD
UMHAT "Sofiamed" OOD, Block 2
"Medical Center - Dr. Hayvazov" EOOD
UMHAT "Prof. Dr. Stoyan Kirkovich" AD
Multiprofile Hospital for active treatment "SVETA PETKA" AD
Dextra Oy/Pihlajalinna Ite Kuopio
Oulu Deaconess Institute
Hôpital Edouard Herriot
Unite Clinique Therapeutique des Maladies Osteoarticulaires
CHR Orleans La Source
Hopital Lariboisiere
Hopital Saint-Antoine
Hôpital Cochin
Hopital Cochin
Praxis Dr. Kronung
Rheumapraxis
Rheumazentrum Prof. Dr. med Gunther Neeck
Kerckhoff Klinik GmbH
Charite Universitaetsmedizin Berlin
CIRI GmbH
Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles
Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.
Obudai Egeszsegugyi Centrum Kft
Qualiclinic Kft.
Jutrix Kft
Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly
Farmacia AOUC Settore Sperimentazione Farmaci
Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -
Azienda Ospedaliera-Universitaria S.Orsola-Malpighi
Farmacia Clinica Puggioli
AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica
Dipartmento di diagnostica per immagini
AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa
Dipartimento Immagini Radiologia
Farmacia Ospedaliera
Azienda Ospedaliero-Universitaria E Policlinico Umberto I
Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,
U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica
Ospedale Civile Maggiore Borgo Trento
Sato Orthopedic Clinic
Kamagaya General Hospital
Fukuoka Mirai Hospital
Shinkokura Hospital
Obase Hospital
Takagi Hospital
Himeno Hospital
Takahashi Orthopedics Clinic
Hakodate Central General Hospital
Hakodate Ohmura Orthopedic Hospital
Obihiro Orthopaedic Hospital
Okubo Hospital
Kobe Kaisei Hospital
Kobe Konan Yamate clinic
National Hospital Organization Sagamihara National Hospital
Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital
Marunouchi Hospital
National Hospital Organization Nagasaki Medical Center
Sobajima Clinic/Orthopedics
National Hospital Organization Osaka Minami Medical Center
Hamamatsu Medical Center
National Hospital Organization Utsunomiya national Hospital
Sonodakai Joint Replacement Center Hospital
Kitasato University Kitasato Institute Hospital
Ohimachi Orthopaedic Clinic
Akita City Hospital
Kyushu Central Hospital
Hiroshima Clinic
Jujo Takeda Rehabilitation Hospital
Nagayoshi General Hospital
NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik
ClinicMed Daniluk, Nowak Społka Jawna
Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska
Centrum Medyczne Pratia Gdynia
Centrum Medyczne Pratia Krakow
Malopolskie Centrum Medyczne S.C
Centrum Terapii Wspolczesnej J.M Jasnorzewska
MTZ Clinical Research Sp. z o.o.
REUMATIKA - Centrum Reumatologii NZOZ
Hospital Conde de Bertiandos
Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz
Hospital Egas Moniz
SC Duo Medical SRL
Centrul Medical SANA S.R.L.
Spitalul Judetean de Urgenta Bacau
Spitalul Clinic "Sf. Maria"
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta
Spitalul Clinic Judetean de Urgenta Sibiu
AB-BA ambulancia s.r.o.
ROMJAN s.r.o.
Kompan, s.r.o
ALGMED s.r.o.
Reum. hapi s.r.o.
Medipa s.r.o.
MUDr. Viliam Cibik, PhD, s.r.o.
Reumex s.r.o
Hospital La Esperanza
Corporacio Sanitaria Parc Tauli de Sabadell
Corporació Sanitaria Parc Taulí de Sabadell
Hospital Universitario Marqués de Valdecilla
Hospital Universitario de Getafe
Complejo Hospital Universitario A Coruna (CHUAC)
Hospital La Esperanza
Instituto de Ciencias Medicas
Instituto de Ciencias Médicas
Hospital del Mar
Hospital CIMA Sanitas
Hospital Universitario Reina Sofia.
Hospital Universitario Reina Sofia
Hospital Universitario de Getafe
Hospital General Universitario de Guadalajara
Hospital Universitario La Princesa Farmacia - Ensayos Clinicos
Hospital Universitario La Princesa
Hospital Universitario La Paz Servicio de Farmacia
Hospital Universitario La Paz
Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil
Hospital Regional Universitario de Malaga
Hospital Infanta Luisa
Ladulaas Kliniska Studier
CTC (Clinical Trial Center), Sahlgrenska University Hospital
ProbarE i Lund AB
PharmaSite
Avdelningen for kliniska provningar, S-huset
ProbarE
Karolinska Trial Alliance, Fas 1
Karolinska Trial Alliance, KTA.
The Alverton Practice
Brannel Surgery
Knowle House Surgery
Western General Hospital
Clinical Trials, Bradford on Avon Health Centre
Health Centre, Bradford on Avon & Melksham Health Partnership
Oxford University Hospitals NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
Northumbria Healthcare NHS Foundation Trust
Nuffield Department of Orthopaedics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose

High dose

Placebo

Arm Description

Investigational product

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24

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 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 the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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 worsening of condition.

Secondary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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).

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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 Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Participants were considered as OMERACT-OARSI responders: if the change (improvement) from baseline to week of interest was greater than or equal to (>=) 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 osteoarthritis. 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 [minimum 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 With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24

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 and 24 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) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response

Percentage of participants with reduction in WOMAC pain intensity of at least (>=) 30%, 50%, 70% and 90% at Weeks 2, 4, 8, 12, 16, 24 and 32 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 Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response

Percentage of participants with reduction in WOMAC physical function of at least (>=)30%,50%,70% and 90% at weeks 2,4,8,12,16,24 and 32 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 Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 16 and 24

Percentage of participants with cumulative reduction (as percent) (greater than 0 %; >= 10 %, 20 %, 30 %, 40 %, 50 %, 60 %, 70 %, 80 % and 90%; =100 %) in WOMAC physical function subscale from Baseline to Weeks 16 and 24 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

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis 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 for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24

Participants assessed their average pain in the index hip/knee in the past 24 hours using 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 8-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 for Average Pain Score in the Index Joint at Weeks 28 and 32

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24

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 32

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 a 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, 12, 16 and 24

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 32

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, 12, 16 and 24

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 32

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 Downstairs) at Weeks 2, 4, 8, 12, 16 and 24

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 Downstairs) at Week 32

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.

Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline

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) Impairment Scores at Weeks 8, 16 and 24

European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score

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. The 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.

European Quality of Life- 5 Dimension-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 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.

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Reported Treatment Impact Assessment-Overall, How Satisfied Are You With The Drug That You Received in This Study?

The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), participant global preference assessment (to assess previous treatment and preference to continue using the investigational product) and participant willingness to use drug again assessment. For participant satisfaction, participants responded using interactive response technology (IRT) on a 5 point likert scale from 1-5, where 1=extremely dissatisfied, 2=dissatisfied, 3=neither satisfied nor dissatisfied, 4=satisfied and 5=extremely satisfied. Higher scores indicated greater satisfaction.

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: Participant Global Preference Assessment- What is The Current or Most Recent Treatment You Were Receiving For Osteoarthritis Pain Before Enrolling?

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: 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 reported treatment impact assessment (to assess participant satisfaction), 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 interactive response technology (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.

Patient Reported Treatment Impact Assessment-Modified (mPRTI) Score at Weeks 16 and 24: 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 reported treatment impact assessment (to assess participant satisfaction), 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 Patient willingness to use drug again, participants responded using interactive response technology (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.

Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Visits of services directly related to osteoarthritis 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

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of participants who visited the emergency room due to osteoarthritis.

Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). 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

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). 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

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). 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

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). 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

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was number of participants who quit job due to OA.

Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was duration since quitting job due to OA.

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, 12, 16 and 24

In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication between day 1 and week 24. 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 32

In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 mg per day up to 5 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 the 4 weeks up to and including the particular study week were summarized.

Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24

In case of inadequate pain relief during the treatment period, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week a 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 at Week 32

In case of inadequate pain relief, after Week 24, acetaminophen/paracetamol up to 4000 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 per week the participants used the rescue medication during the 4 weeks up to and including the particular study week were summarized.

Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24

In case of inadequate pain relief, acetaminophen/paracetamol up to 4000 mg per day up to 5 days in a week could be taken as rescue medication. The total dosage of acetaminophen in milligrams used during the specified week were summarized.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study

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 48 that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study

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 48 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; WBC count<0.6*LLN, >1.5*ULN; Lymphocytes,Leukocytes,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 Glucose, protein,HGB,bilirubin >=1; Ketones>=1;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, Leukocytes, Neutrophils <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; Nitrite >=1.

Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48

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, 12, 16, 24, 32 and 48

Heart rate was measured at sitting position.

Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48

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, QTcF, RR intervals) were collected.

Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48

Heart rate was measured at sitting position.

Percentage of Participants With Adjudicated Joint Safety Outcomes

Incidence of participants with any of the joint safety adjudication outcomes of primary osteonecrosis, rapidly progressive OA (type 1 and type 2), subchondral insufficiency fracture (or SPONK), or pathological fracture.

Percentage of Participants With Total Joint Replacements

Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.

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 Week 24

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, 12, 16, 24, 32 and 48

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 ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using a semi quantitative enzyme linked immunosorbent assay (ELISA). Participants listed as having anti-tanezumab antibodies had ADA titer level >=3.32. Less than 3.32 was considered below the limit of quantitation.

Full Information

NCT ID

NCT02709486

First Posted

February 26, 2016

Last Updated

June 6, 2019

Sponsor

Pfizer

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02709486

Brief Title

Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

Official Title

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

March 2, 2016 (Actual)

Primary Completion Date

June 8, 2018 (Actual)

Study Completion Date

November 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

Detailed Description

This is a randomized, double blind, placebo controlled, parallel group multicenter Phase 3 study of the efficacy and safety of tanezumab when administered by SC injection for 24 weeks compared to placebo in subjects with osteoarthritis of the knee or hip. A total of approximately 810 subjects will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (ie, 270/group). The randomization will be stratified by index joint (hip or knee), and most severe Kellgren-Lawrence grade (of any knee or hip joint) at study entry (grade 2, 3 or 4). Subjects will receive up to three SC doses of one of the following treatments at an 8-week interval between each injection: tanezumab 2.5 mg; tanezumab 5 mg; Placebo to match tanezumab. The study is designed with a total (post-randomization) duration of 48 weeks and will consist of three periods: Screening (up to 37 days), Double-blind Treatment (24 weeks) and Safety Follow-up (24 weeks). The Screening Period (beginning up to 37 days prior to Randomization) includes a Washout Period (lasting a minimum of 2 days for all prohibited pain medications), if required, and an Initial Pain Assessment Period (the 7 days prior to Randomization/Baseline). Week 24 is the landmark analysis in this study. Subjects who do not complete the Double-blind Treatment period will enter and complete the 24-week Early-termination follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip, Osteoarthritis, Knee

Keywords

Osteoarthritis, pain, tanezumab.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

849 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose

Arm Type

Experimental

Arm Description

Investigational product

Arm Title

High dose

Arm Type

Experimental

Arm Description

Investigational product

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Investigational product

Intervention Type

Drug

Intervention Name(s)

Tanezumab

Intervention Description

2.5 mg

Intervention Type

Drug

Intervention Name(s)

Tanezumab

Intervention Description

5 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in the Patient's Global Assessment (PGA) of Osteoarthritis at Week 24

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12 and 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 32

Description

Time Frame

Baseline, Week 32

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12 and 16

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 32

Description

Time Frame

Baseline, Week 32

Title

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16

Description

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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).

Time Frame

Baseline, Weeks 2, 4, 8, 12 and 16

Title

Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis at Week 32

Description

PGA of OA was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip (index joint) 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.

Time Frame

Baseline, Week 32

Title

Percentage of Participants Meeting Outcomes Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24 and 32

Title

Percentage of Participants With Cumulative Percent Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 16 and 24

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 and 24 were reported, participants (%) are reported more than once in categories specified. Missing data was imputed using mixed BOCF/LOCF.

Time Frame

Baseline, Weeks 16 and 24

Title

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Reduction >=30 Percent (%), >=50%, >=70% and >=90% Response

Description

Time Frame

Week 2, 4, 8, 12, 16, 24 and 32

Title

Percentage of Participants Achieving Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Reduction >=30%, >=50%, >=70% and >=90% Response

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24 and 32

Title

Description

Time Frame

Baseline, Weeks 16 and 24

Title

Percentage of Participants Achieving Improvement of >=2 Points in Patient's Global Assessment (PGA) of Osteoarthritis

Description

Time Frame

Weeks 2, 4, 8, 12, 16, 24 and 32

Title

Change From Baseline for Average Pain Score in the Index Joint at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24

Description

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24

Title

Change From Baseline for Average Pain Score in the Index Joint at Weeks 28 and 32

Description

Time Frame

Baseline, Weeks 28 and 32

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Weeks 2, 4, 8, 12, 16 and 24

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16 and 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 32

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 a 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 32

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16 and 24

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, 12, 16 and 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 32

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 32

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, 12, 16 and 24

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, 12, 16 and 24

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 32

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 32

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Weeks 2, 4, 8, 12, 16 and 24

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, 12, 16 and 24

Title

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Going Up or Downstairs) at Week 32

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 32

Title

Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Scores at Baseline

Description

Time Frame

Baseline

Title

Change From Baseline in Work Productivity and Activity Impairment Questionnaire for Osteoarthritis (WPAI:OA) Impairment Scores at Weeks 8, 16 and 24

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Dimensions Score

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

European Quality of Life- 5 Dimension-5 Levels (EQ-5D-5L) Overall Health Utility Score/ Index Value

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Description

Time Frame

Weeks 16 and 24

Title

Description

Time Frame

Weeks 16 and 24

Title

Description

The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), 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 interactive response technology (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.

Time Frame

Weeks 16 and 24

Title

Description

The mPRTI is a self-administered questionnaire containing participant reported treatment impact assessment (to assess participant satisfaction), 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 Patient willingness to use drug again, participants responded using interactive response technology (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.

Time Frame

Weeks 16 and 24

Title

Health Care Resource Utilization (HCRU): Number of Visits of Services Directly Related to Osteoarthritis

Description

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Visited the Emergency Room Due to Osteoarthritis

Description

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Visits to the Emergency Room Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of visits to the emergency room due to OA.

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Participants Hospitalized Due to Osteoarthritis

Description

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Nights Stayed in the Hospital Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage during last 3 months (for Baseline and Week 48) and past 8 weeks (for Week 32). Domain evaluated was number of nights stayed in the hospital due to OA.

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Used Any Aids/Devices for Doing Things

Description

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Number of Participants Who Quit Job Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was number of participants who quit job due to OA.

Time Frame

Baseline, Weeks 32 and 48

Title

Health Care Resource Utilization (HCRU): Duration Since Quitting Job Due to Osteoarthritis

Description

Osteoarthritis HCRU assessed healthcare usage (during 3 months prior to baseline) at baseline, Week 32 and Week 48. Domain evaluated was duration since quitting job due to OA.

Time Frame

Baseline, Weeks 32 and 48

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 24

Title

Time to Discontinuation Due to Lack of Efficacy

Description

Time Frame

Baseline up to Week 24

Title

Number of Participants Who Took Rescue Medication During Weeks 2, 4, 8, 12, 16 and 24

Description

Time Frame

Weeks 2, 4, 8, 12, 16 and 24

Title

Number of Participants Who Took Rescue Medication During Week 32

Description

Time Frame

Week 32

Title

Number of Days of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24

Description

Time Frame

Weeks 2, 4, 8, 12, 16 and 24

Title

Number of Days of Rescue Medication Used at Week 32

Description

Time Frame

Week 32

Title

Amount of Rescue Medication Used at Weeks 2, 4, 8, 12, 16 and 24

Description

Time Frame

Weeks 2, 4, 8, 12, 16 and 24

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study

Description

Time Frame

Baseline up to Week 48

Title

Number of Participants With Treatment-Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) up to End of Study

Description

Time Frame

Baseline up to Week 48

Title

Number of Participants With Laboratory Test Abnormalities With Regard to Normal Baseline

Description

Time Frame

Baseline up to Week 48

Title

Number of Participants With Laboratory Test Abnormalities With Regard to Abnormal Baseline

Description

Time Frame

Baseline up to Week 48

Title

Change From Baseline in Blood Pressure (BP) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Description

Measurement of BP included sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP).

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Title

Change From Baseline in Heart Rate at Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Description

Heart rate was measured at sitting position.

Time Frame

Baseline, Weeks 2, 4, 8, 12,16, 24, 32 and 48

Title

Change From Baseline in Electrocardiogram (ECG) Parameters at Weeks 24 and 48

Description

Time Frame

Baseline, Weeks 24 and 48

Title

Change From Baseline in Heart Rate (as Assessed by ECG) at Weeks 24 and 48

Description

Heart rate was measured at sitting position.

Time Frame

Baseline, Weeks 24 and 48

Title

Percentage of Participants With Adjudicated Joint Safety Outcomes

Description

Time Frame

Baseline up to Week 48

Title

Percentage of Participants With Total Joint Replacements

Description

Percentage of participants who underwent at least one total knee, hip or shoulder joint replacement surgery.

Time Frame

Baseline up to Week 48

Title

Number of Participants With Confirmed Orthostatic Hypotension

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Title

Change From Baseline in Survey of Autonomic Symptom (SAS) Scores at Week 24

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Description

Time Frame

Baseline, Weeks 2, 4, 8, 12, 16, 24, 32 and 48

Title

Number of Participants With Anti Tanezumab Antibodies

Description

Time Frame

Baseline, Weeks 8,16, 24, 32 and 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 at least 2 as diagnosed by the Central Reader A history of insufficient pain relief from acetaminophen along with a history of insufficient pain relief from, inability to tolerate or contraindication to taking NSAIDs, and tramadol or opioid treatments. WOMAC Pain subscale score of at least 5 in the index hip or knee 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 (e.g. 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 (e.g. fibromyalgia, 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. 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

Nuhr Medical Center

City

Senftenberg

ZIP/Postal Code

3541

Country

Austria

Facility Name

Rheuma Zentrum Favoriten

City

Wien

ZIP/Postal Code

1100

Country

Austria

Facility Name

Medical Center BLAGOEVGRAD 2009, EOOD

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

DCC St. Pantaleimon OOD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Medical Center " Health for all" EOOD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

UMHAT Kaspela

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

"Medical Center Teodora" EOOD

City

Ruse

ZIP/Postal Code

7012

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment-Silistra AD

City

Silistra

ZIP/Postal Code

7500

Country

Bulgaria

Facility Name

"Medical Center- Smolyan" OOD

City

Smolyan

ZIP/Postal Code

4700

Country

Bulgaria

Facility Name

NMTH 'Tsar Boris III". Clinic of Internal Diseases

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Multiprofile hospital for active treatment - "Lyulin" EAD

City

Sofia

ZIP/Postal Code

1336

Country

Bulgaria

Facility Name

Diagnostic Consultative Center XIV- Sofia EOOD

City

Sofia

ZIP/Postal Code

1408

Country

Bulgaria

Facility Name

Medical Center-Avicena EOOD

City

Sofia

ZIP/Postal Code

1408

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

UMHAT "Prof. Dr. Stoyan Kirkovich" AD

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Multiprofile Hospital for active treatment "SVETA PETKA" AD

City

Vidin

ZIP/Postal Code

3700

Country

Bulgaria

Facility Name

Dextra Oy/Pihlajalinna Ite Kuopio

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

Oulu Deaconess Institute

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

Hôpital Edouard Herriot

City

Lyon

ZIP/Postal Code

69003

Country

France

Facility Name

Unite Clinique Therapeutique des Maladies Osteoarticulaires

City

Montpellier Cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

CHR Orleans La Source

City

Orleans

ZIP/Postal Code

45067

Country

France

Facility Name

Hopital Lariboisiere

City

Paris cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Hopital Saint-Antoine

City

Paris cedex 12

ZIP/Postal Code

75571

Country

France

Facility Name

Hôpital Cochin

City

Paris cedex 14

ZIP/Postal Code

75659

Country

France

Facility Name

Hopital Cochin

City

Paris cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Praxis Dr. Kronung

City

Offenbach

State/Province

Hesse

ZIP/Postal Code

63073

Country

Germany

Facility Name

Rheumapraxis

City

Aachen

ZIP/Postal Code

52064

Country

Germany

Facility Name

Rheumazentrum Prof. Dr. med Gunther Neeck

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

Kerckhoff Klinik GmbH

City

Bad Nauheim

ZIP/Postal Code

61231

Country

Germany

Facility Name

Charite Universitaetsmedizin Berlin

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

CIRI GmbH

City

Frankfurt am Main

ZIP/Postal Code

60590

Country

Germany

Facility Name

Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles

City

Bekescsaba

ZIP/Postal Code

5600

Country

Hungary

Facility Name

Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

City

Budapest

ZIP/Postal Code

1033

Country

Hungary

Facility Name

Obudai Egeszsegugyi Centrum Kft

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Jutrix Kft

City

Kecskemét

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

City

Szekszard

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Farmacia AOUC Settore Sperimentazione Farmaci

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -

City

Rozzano

State/Province

Milan

ZIP/Postal Code

20089

Country

Italy

Facility Name

Azienda Ospedaliera-Universitaria S.Orsola-Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Farmacia Clinica Puggioli

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

Dipartmento di diagnostica per immagini

City

Firenze

ZIP/Postal Code

50134

Country

Italy

Facility Name

AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Dipartimento Immagini Radiologia

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Farmacia Ospedaliera

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria E Policlinico Umberto I

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Ospedale Civile Maggiore Borgo Trento

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Sato Orthopedic Clinic

City

Ichikawa

State/Province

Chiba

ZIP/Postal Code

272-0021

Country

Japan

Facility Name

Kamagaya General Hospital

City

Kamagaya

State/Province

Chiba

ZIP/Postal Code

273-0121

Country

Japan

Facility Name

Fukuoka Mirai Hospital

City

Higashi-ku,Fukuoka

State/Province

Fukuoka

ZIP/Postal Code

813-0017

Country

Japan

Facility Name

Shinkokura Hospital

City

Kitakyushu

State/Province

Fukuoka

ZIP/Postal Code

803-8505

Country

Japan

Facility Name

Obase Hospital

City

Miyako-gun

State/Province

Fukuoka

ZIP/Postal Code

800-0344

Country

Japan

Facility Name

Takagi Hospital

City

Okawa

State/Province

Fukuoka

ZIP/Postal Code

831-0016

Country

Japan

Facility Name

Himeno Hospital

City

Yamegun

State/Province

Fukuoka

ZIP/Postal Code

834-0115

Country

Japan

Facility Name

Takahashi Orthopedics Clinic

City

Chitose

State/Province

Hokkaido

ZIP/Postal Code

066-0062

Country

Japan

Facility Name

Hakodate Central General Hospital

City

Hakodate

State/Province

Hokkaido

ZIP/Postal Code

040-8585

Country

Japan

Facility Name

Hakodate Ohmura Orthopedic Hospital

City

Hakodate

State/Province

Hokkaido

ZIP/Postal Code

041-0802

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

Kobe Kaisei Hospital

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

657-0068

Country

Japan

Facility Name

Kobe Konan Yamate clinic

City

Kobe

State/Province

Hyogo

ZIP/Postal Code

658-0011

Country

Japan

Facility Name

National Hospital Organization Sagamihara National Hospital

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0392

Country

Japan

Facility Name

Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

226-0025

Country

Japan

Facility Name

Marunouchi Hospital

City

Matsumoto

State/Province

Nagano

ZIP/Postal Code

390-8601

Country

Japan

Facility Name

National Hospital Organization Nagasaki Medical Center

City

Omura

State/Province

Nagasaki

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

Sobajima Clinic/Orthopedics

City

Higashiosaka

State/Province

Osaka

ZIP/Postal Code

577-0011

Country

Japan

Facility Name

National Hospital Organization Osaka Minami Medical Center

City

Kawachinagano

State/Province

Osaka

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Hamamatsu Medical Center

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

432-8580

Country

Japan

Facility Name

National Hospital Organization Utsunomiya national Hospital

City

Utsunomiya

State/Province

Tochigi

ZIP/Postal Code

329-1193

Country

Japan

Facility Name

Sonodakai Joint Replacement Center Hospital

City

Adachi-ku

State/Province

Tokyo

ZIP/Postal Code

121-0064

Country

Japan

Facility Name

Kitasato University Kitasato Institute Hospital

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

108-8642

Country

Japan

Facility Name

Ohimachi Orthopaedic Clinic

City

Shinagawa-ku

State/Province

Tokyo

ZIP/Postal Code

140-0014

Country

Japan

Facility Name

Akita City Hospital

City

Akita

ZIP/Postal Code

010-0933

Country

Japan

Facility Name

Kyushu Central Hospital

City

Fukuoka

ZIP/Postal Code

815-8588

Country

Japan

Facility Name

Hiroshima Clinic

City

Hiroshima

ZIP/Postal Code

733-0032

Country

Japan

Facility Name

Jujo Takeda Rehabilitation Hospital

City

Kyoto

ZIP/Postal Code

601-8325

Country

Japan

Facility Name

Nagayoshi General Hospital

City

Osaka

ZIP/Postal Code

547-0016

Country

Japan

Facility Name

NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

ClinicMed Daniluk, Nowak Społka Jawna

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Centrum Medyczne Pratia Gdynia

City

Gdynia

ZIP/Postal Code

81-338

Country

Poland

Facility Name

Centrum Medyczne Pratia Krakow

City

Krakow

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Malopolskie Centrum Medyczne S.C

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Centrum Terapii Wspolczesnej J.M Jasnorzewska

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

REUMATIKA - Centrum Reumatologii NZOZ

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Hospital Conde de Bertiandos

City

Ponte De Lima

State/Province

Viana DO Castelo

ZIP/Postal Code

4990-041

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

Hospital Egas Moniz

City

Lisboa

ZIP/Postal Code

1349-019

Country

Portugal

Facility Name

SC Duo Medical SRL

City

Bucuresti

State/Province

Sector 1

ZIP/Postal Code

010584

Country

Romania

Facility Name

Centrul Medical SANA S.R.L.

City

Bucuresti

State/Province

Sector 1

ZIP/Postal Code

011025

Country

Romania

Facility Name

Spitalul Judetean de Urgenta Bacau

City

Bacau

ZIP/Postal Code

600114

Country

Romania

Facility Name

Spitalul Clinic "Sf. Maria"

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Sibiu

City

Sibiu

ZIP/Postal Code

550245

Country

Romania

Facility Name

AB-BA ambulancia s.r.o.

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

ROMJAN s.r.o.

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Kompan, s.r.o

City

Dolny Kubín

ZIP/Postal Code

02601

Country

Slovakia

Facility Name

ALGMED s.r.o.

City

Kosice

ZIP/Postal Code

040 01

Country

Slovakia

Facility Name

Reum. hapi s.r.o.

City

Nove Mesto nad Vahom

ZIP/Postal Code

915 01

Country

Slovakia

Facility Name

Medipa s.r.o.

City

Piestany

ZIP/Postal Code

921 01

Country

Slovakia

Facility Name

MUDr. Viliam Cibik, PhD, s.r.o.

City

Pruske

ZIP/Postal Code

018 52

Country

Slovakia

Facility Name

Reumex s.r.o

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

Hospital La Esperanza

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15705

Country

Spain

Facility Name

Corporacio Sanitaria Parc Tauli de Sabadell

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Corporació Sanitaria Parc Taulí de Sabadell

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Hospital Universitario Marqués de Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Hospital Universitario de Getafe

City

Getafe

State/Province

Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

Complejo Hospital Universitario A Coruna (CHUAC)

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital La Esperanza

City

A Coruña

ZIP/Postal Code

15705

Country

Spain

Facility Name

Instituto de Ciencias Medicas

City

Alicante

ZIP/Postal Code

03004

Country

Spain

Facility Name

Instituto de Ciencias Médicas

City

Alicante

ZIP/Postal Code

03004

Country

Spain

Facility Name

Hospital del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hospital CIMA Sanitas

City

Barcelona

ZIP/Postal Code

08034

Country

Spain

Facility Name

Hospital Universitario Reina Sofia.

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario de Getafe

City

Getafe, Madrid

ZIP/Postal Code

28905

Country

Spain

Facility Name

Hospital General Universitario de Guadalajara

City

Guadalajara

ZIP/Postal Code

19002

Country

Spain

Facility Name

Hospital Universitario La Princesa Farmacia - Ensayos Clinicos

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario La Paz Servicio de Farmacia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Universitario La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hospital Regional Universitario de Malaga

City

Malaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hospital Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Ladulaas Kliniska Studier

City

Boras

ZIP/Postal Code

SE-50630

Country

Sweden

Facility Name

CTC (Clinical Trial Center), Sahlgrenska University Hospital

City

Gothenburg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

ProbarE i Lund AB

City

Lund

ZIP/Postal Code

222 22

Country

Sweden

Facility Name

PharmaSite

City

Malmo

ZIP/Postal Code

211 52

Country

Sweden

Facility Name

Avdelningen for kliniska provningar, S-huset

City

Orebro

ZIP/Postal Code

703 62

Country

Sweden

Facility Name

ProbarE

City

Stockholm

ZIP/Postal Code

11137

Country

Sweden

Facility Name

Karolinska Trial Alliance, Fas 1

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Karolinska Trial Alliance, KTA.

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

The Alverton Practice

City

Penzance

State/Province

Cornwall

ZIP/Postal Code

TR18 4JH

Country

United Kingdom

Facility Name

Brannel Surgery

City

St. Austell

State/Province

Cornwall

ZIP/Postal Code

PL26 7RL

Country

United Kingdom

Facility Name

Knowle House Surgery

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL5 3JB

Country

United Kingdom

Facility Name

Western General Hospital

City

Edinburgh

State/Province

Midlothian

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Clinical Trials, Bradford on Avon Health Centre

City

Bradford on Avon

ZIP/Postal Code

BA13 1DQ

Country

United Kingdom

Facility Name

Health Centre, Bradford on Avon & Melksham Health Partnership

City

Bradford on Avon

ZIP/Postal Code

BA15 1DQ

Country

United Kingdom

Facility Name

Oxford University Hospitals NHS Foundation Trust

City

Headington, Oxford

ZIP/Postal Code

OX3 7LD

Country

United Kingdom

Facility Name

St George's University Hospitals NHS Foundation Trust

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Northumbria Healthcare NHS Foundation Trust

City

North Shields

ZIP/Postal Code

NE29 8NH

Country

United Kingdom

Facility Name

Nuffield Department of Orthopaedics

City

Oxford

ZIP/Postal Code

OX3 7HE

Country

United Kingdom

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

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

35105318

Citation

Conaghan PG, Abraham L, Viktrup L, Cislo P. Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 1;23(1):106. doi: 10.1186/s12891-022-05029-x.

Results Reference

derived

PubMed Identifier

34626502

Citation

Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.

Results Reference

derived

PubMed Identifier

33973384

Citation

Berenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.

Results Reference

derived

PubMed Identifier

33728717

Citation

Berenbaum F, Langford R, Perrot S, Miki K, Blanco FJ, Yamabe T, Isogawa N, Junor R, Carey W, Viktrup L, West CR, Brown MT, Verburg KM. Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained? Eur J Pain. 2021 Aug;25(7):1525-1539. doi: 10.1002/ejp.1764. Epub 2021 May 3.

Results Reference

derived

PubMed Identifier

32234715

Citation

Berenbaum F, Blanco FJ, Guermazi A, Miki K, Yamabe T, Viktrup L, Junor R, Carey W, Brown MT, West CR, Verburg KM. Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091057

Description

To obtain contact information for a study center near you, click here.

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091057&StudyName=A+Phase+3+Randomized%2C+Double-blind%2C+Placebo-controlled%2C+Multicenter+Study+Of+The+Analgesic+Efficacy+And+Safety+Of+The+Subcutaneous+Administration+Of+Tanezumab+In+Subjects+With+Osteoarthritis+Of+The+Hip+Or+Knee

Description

To obtain contact information for a study center near you, click here.

Learn more about this trial

Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

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