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Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tanezumab
diclofenac
tanezumab
diclofenac
tanezumab
diclofenac
diclofenac
IV placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA

Eligibility Criteria

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

Inclusion Criteria:

  • Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2.
  • Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen.
  • Pain and function levels as required by the protocol at Screening and Baseline.
  • Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol.
  • Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

  • Pregnant women.
  • BMI greater than 39.
  • History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors.
  • Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA.
  • Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening.
  • Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities.
  • History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder.
  • At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women.
  • Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening.
  • Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).

Sites / Locations

  • LKH-Medizinische Universitatsklinik Graz
  • Nuhr Zentrum
  • ClinPharm International GmbH
  • Medizinische Universitaet Wien/AKH
  • Rheuma Zentrum Favoriten
  • CHU de Nantes
  • Hopital Lariboisiere
  • Viereck-Apotheke
  • Charité-Universitaetsmedizin Berlin
  • Klinische Forschung Berlin-Buch GmbH
  • Apotheke
  • Herz Apotheke
  • Synexus ClinPharm GmbH
  • Synexus ClinParm GmbH
  • Apotheke im Arztehaus Mickten
  • Schiller Apotheke & Stadt Apotheke
  • Schmerz- und Palliativzentrum Goeppingen
  • Falken Apotheke Hoheluft
  • Klinische Forschung Hamburg GmbH
  • Klinische Forschung Hannover - Mitte GmbH
  • Loewen-Apotheke
  • Synexus ClinPharm GmbH
  • Arkana Apotheke OHG
  • Synexus ClinPharm GmbH
  • Apotheke im MSZ
  • Apotheke des Ernst von Bergmann Klinikums
  • Synexus ClinParm GmbH
  • Kirchsteig Apotheke
  • "Centrum Medyczne MEDENS S.C. Niepubliczny Zaklad
  • Malopolskie Centrum Medyczne s.c.
  • Centrum Medyczne OSTEOMED Sp. z o. o.
  • Synexus SCM Sp. z o.o.
  • Niepubliczny Zaklad Opieki Zdrowotnej "POLIMEDICA"
  • Municipal Hospital No. 1 "Schuller"
  • Clinical Emergency Military Hospital "Dr. Carol Davila"
  • Duo Medical srl
  • Medical Center "SANA"
  • Clinical Hospital "Sf. Maria"
  • Center of Rheumatology "Dr Ion Stoia"
  • Clinical Emergency County Hospital Constanta
  • County Emergency Clinic Hospital "Sf. Apostol Andrei"
  • Center polyclinic of Federal State Institution
  • State Healthcare Institution of Moscow city "City Clinical Hospital #15 n.a. O. M. Filatov"
  • Chair of Hospital Therapy of Ryazan State Medical University
  • St. Petersburg State Healthcare Institution "City Hospital #25 City Rheumatology Center"
  • State Educational Institution of Additional Professional Education
  • Institution of Russian Academy of Sciences "St. Petersburg Clinical Hospital of RAS"
  • St. Petersburg State Healthcare Institution "City Outpatient Clinical #51"
  • St. Petersburg State Healthcare Institution "City Pokrovskaya Hospital"
  • Hospital Nuestra Señora de la Esperanza
  • Centro Salud Petrer 1
  • Hospital de Basurto
  • Hospital Comarcal de Elda
  • Hospital Universitario Getafe
  • Hospital G. U. Gregorio Maranon
  • Hospital Clinico Universitario Santiago
  • Me3plus AB
  • Me3plus AB
  • Center for Lakemedelsstudier
  • Medicinskt Centrum
  • Chernivtsi Regional Clinical Hospital,Department of Rheumatology
  • Road Clinical Hospital at Dnipropetrovsk station, Department of Rheumatology
  • Institute of Urgent and Recovery Surgery named after V.K. Gusaka AMS Ukraine
  • Central City Clinical Hospital#1, Department of Therapy,
  • Ivano-Frankivsk Regional Clinical Hospital
  • City Clinical Hospital #8, Department of reumatology,
  • State Institution "Institute of Gerontology AMS of Ukraine"
  • Oleksandrivska Clinical Hospital in Kyiv-Department of Rheumatology # 1
  • Kyiv Central Basin Clinical Hospital, Department of cardiology,
  • 4th City Communal Clinical Hospital, Department of Rheumatology,
  • City communal clinical hospital #5, Dept. of Therapy, Danylo Galytskiy Lviv National Med. University
  • Communal Institution Ternopil regional council, "Ternopil Regional Clinical Hospital"
  • Vinnytsya regional clinical hospital named after M.I. Pyrogova
  • Communal institution "City Hospital #7", Department of Therapy,
  • Barnsley Hospital NHS Trust
  • Department of Rheumatology
  • Wrightington Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Tanezumab 10 mg + diclofenac

Tanezumab 5 mg + diclofenac

Tanezumab 2.5 mg + diclofenac

IV placebo + diclofenac

Arm Description

IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition.

Secondary Outcome Measures

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 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. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition.
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF
OMERACT-OARSI responder: participant has >=50 percent (%) change and >=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: >=20% change and >=1 absolute change from Baseline in WOMAC pain subscale; >=20% change and >=1 absolute change from Baseline in the WOMAC physical function subscale; >=20% change and >=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 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 osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. 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.
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. 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.
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement.
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF)
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement.
Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24
Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12, 16, and 24
WOMAC Index: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement.
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
Participants answered the question: "How much pain have you had when walking on a flat surface?" Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
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
Participants answered the question: "How much pain have you had when going up or down the stairs?" Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24
SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24
SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population.
Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening.
Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants "no dysfunction, moderate or some dysfunction and extreme dysfunction" and change from baseline in EQ-5D individual health state profile was determined as number of participants "improved, no change or worsened".
Number of Participants Who Discontinued Due to Lack of Efficacy
Number of participants who discontinued due to lack of efficacy were reported.
Time to Discontinuation (TTD) Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.

Full Information

First Posted
March 17, 2009
Last Updated
February 8, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00864097
Brief Title
Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip
Official Title
A PHASE 3, RANDOMIZED, DOUBLE BLIND, CONTROLLED, MULTI CENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ADDED ON TO DICLOFENAC SR IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
August 11, 2009 (Actual)
Primary Completion Date
November 16, 2010 (Actual)
Study Completion Date
November 24, 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.
Detailed Description
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tanezumab 10 mg + diclofenac
Arm Type
Experimental
Arm Description
IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
Arm Title
Tanezumab 5 mg + diclofenac
Arm Type
Experimental
Arm Description
IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
Arm Title
Tanezumab 2.5 mg + diclofenac
Arm Type
Experimental
Arm Description
IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
Arm Title
IV placebo + diclofenac
Arm Type
Placebo Comparator
Arm Description
IV placebo to match tanezumab every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32)
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
IV tanezumab 10 mg every 8 weeks (through Week 16)
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
Oral diclofenac SR 75 mg BID for 32 weeks
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
IV tanezumab 5 mg every 8 weeks (through Week 16)
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
Oral diclofenac SR 75 mg BID for 32 weeks
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
IV tanezumab 2.5 mg every 8 weeks (through Week 16)
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
Oral diclofenac SR 75 mg BID for 32 weeks
Intervention Type
Drug
Intervention Name(s)
diclofenac
Intervention Description
Oral diclofenac SR 75 mg BID for 32 weeks
Intervention Type
Other
Intervention Name(s)
IV placebo
Intervention Description
IV placebo to match tanezumab every 8 weeks (through Week 16)
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Week 16
Description
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 24
Title
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, 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. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 24
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis Score at Weeks 2, 4, 8, 12, and 24
Description
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition.
Time Frame
Baseline, Weeks 2, 4, 8, 12, and 24
Title
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response; LOCF
Description
OMERACT-OARSI responder: participant has >=50 percent (%) change and >=2 absolute change from Baseline in either WOMAC pain or physical function subscale scores or at least 2 of the following being true: >=20% change and >=1 absolute change from Baseline in WOMAC pain subscale; >=20% change and >=1 absolute change from Baseline in the WOMAC physical function subscale; >=20% change and >=1 absolute change from Baseline in PGA of osteoarthritis. WOMAC pain and physical function score: 0 to 10 with higher score = worse response. PGA score: 1 = very good and 5 = very poor.
Time Frame
Weeks 2, 4, 8, 12, 16, and 24
Title
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 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 osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. 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.
Time Frame
Baseline, Week 16 and 24
Title
Percentage of Participants With At Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score; LOCF
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Greater percentage reduction indicates greater improvement. 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.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Title
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; LOCF
Description
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicated improvement.
Time Frame
Weeks 2, 4, 8, 12, 16, and 24
Title
Percentage of Participants With Improvement of at Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis; Baseline Observation Carried Forward (BOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your index joint (knee/hip) affects you, how are you doing today?" Participants responded by using a 5-point Likert scale, where 1 = very good (asymptomatic 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 which are intolerable and inability to carry out all normal activities). Higher score indicated worst condition. A decrease of at least 2 points on the 5-point scale relative to baseline value indicates improvement.
Time Frame
Weeks 2, 4, 8, 12, 16, and 24
Title
Change From Baseline in Average Pain Score in the Index Knee or Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24
Description
Participants were asked to assess index joint (knee/hip) pain during the past 24 hours on an 0-10 point integer scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline score was calculated as the mean of the scores in the index joint over the 3 days days in the initial pain assessment period and a weekly mean was calculated using the daily pain scores in the index joint within each study week. The change from Baseline was calculated using the difference between each post-baseline weekly mean and the baseline mean score, where negative change indicated an improvement.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, and 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale 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. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in index knee or hip during past 48 hours. It is calculated as mean of the scores from 2 individual questions scored on NRS of (no stiffness) to 10 (extreme stiffness), with higher scores indicate higher stiffness. Total score range for WOMAC stiffness subscale score is (no stiffness) to 10 (extreme stiffness), where higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of knee/hip. Negative change indicated an improvement.
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 Weeks 2, 4, 8, 12, 16, and 24
Description
WOMAC Index: self-administered, disease-specific 24 item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items), and physical function (17 items) in participants with osteoarthritis of the hip and/or knee. WOMAC average score is the mean of the WOMAC pain, physical function and stiffness subscale scores and ranges from 0 to 10, with higher score indicating worse response. Greater reduction in WOMAC average score indicated greater improvement.
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 Weeks 2, 4, 8, 12, 16, and 24
Description
Participants answered the question: "How much pain have you had when walking on a flat surface?" Participants responded by using an 11-point scale where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
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
Participants answered the question: "How much pain have you had when going up or down the stairs?" Participants responded by using an 11-point scale, where 0 = no pain and 10 = extreme pain. Where 0 is the best response and negative change indicated an improvement.
Time Frame
Baseline, Weeks 2, 4, 8, 12, 16, and 24
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24
Description
SF-36v2 was a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and role limitations due to emotional problems, bodily pain, general health, vitality, and mental health. The total score and the score for a section was an average of the individual question scores, which were scaled 0-100. Higher scores reflected better participant status and positive change indicated an improvement.
Time Frame
Baseline, Week 12, and 24
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24
Description
SF-36v2: standardized survey evaluating 8 aspects of functional health and wellbeing (physical and social functioning, role limitations due to physical and emotional problems, bodily pain, general health, vitality, mental health). Total score for each aspect were scaled 0-100. Higher scores reflect better participant status and positive change indicated an improvement. For obtaining physical and mental component scores, z-score for each scale=(observed score - mean score for general 1990 United States [US] population)/corresponding standard deviation. The 2 component scores were obtained by multiplying each aspect z-score by physical or mental factor score coefficient (1990 general US population) and summing the eight products. Component scores indicated how many standard deviations higher (in case of positive z-score [better functioning])/lower (in case of negative z-score [worse functioning]) participant's value was relative to the mean of the reference population.
Time Frame
Baseline, Week 12 and 24
Title
Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Index Score at Week 24
Description
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). EQ-5D summary index was obtained with a formula that weights each level of the dimensions. The index-based score was interpreted along a continuum of 0 (death) to 1 (perfect health). Negative change from baseline represented worsening.
Time Frame
Baseline, Week 24
Title
Number of Participants With Change From Baseline in European Quality of Life - 5 Dimension (EQ-5D) Individual Health State Profile at Week 24
Description
EQ-5D was a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme dysfunction) and a single index value characterizing current health status using a visual analog scale with score ranging from 0 (worst) to 100 (best). Baseline EQ-5D individual health state profile was determined as number of participants "no dysfunction, moderate or some dysfunction and extreme dysfunction" and change from baseline in EQ-5D individual health state profile was determined as number of participants "improved, no change or worsened".
Time Frame
Baseline, Week 24
Title
Number of Participants Who Discontinued Due to Lack of Efficacy
Description
Number of participants who discontinued due to lack of efficacy were reported.
Time Frame
Baseline up to end of study (Week 32)
Title
Time to Discontinuation (TTD) Due to Lack of Efficacy
Description
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Time Frame
Baseline up to Week 16 and 24
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
Time Frame
Baseline up to 112 days after last intravenous dose (up to Week 32)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Intravenous Doses of Study Medication
Description
Number of participants were reported based on the maximum number of intravenous (IV) doses of either tanezumab or placebo received.
Time Frame
Day 1 up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence X-ray grade equal to, or greater than, 2. Patients must be experiencing some benefit from their current stable dose regimen of oral diclofenac 150 mg/day and be tolerating their diclofenac regimen. Pain and function levels as required by the protocol at Screening and Baseline. Willing to discontinue all non-study pain medications throughout the study except as permitted per protocol. Willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests and other study procedures. Exclusion Criteria: Pregnant women. BMI greater than 39. History of other disease that may involve index knee or hip including inflammatory joint diseases, chrystalline disease (gout or pseudogout), endocrinopathies, metabolic joint diseases, lupus erythematosus, rheumatoid arthritis (RA), joint infections, neuropathic disorders, avascular necrosis, Paget's disease or tumors. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA. Signs and symptoms of clinically significant cardiac disease within 6 months prior to screening. Diagnosis or TIA within 6 months prior to screening or diagnosis of stroke with residual deficits that would preclude completion of required study activities. History, diagnosis , signs or symptoms of clinically significant neurological and/or psychiatric disease/disorder. At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%, ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 150 micro-mol/L in men or 133 micro-mol/L in women. Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy within 30 days prior to Screening. Known hypersensitivity to NSAIDs (eg, diclofenac), cyclooxygenase inhibitors or paracetamol (acetaminophen).
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
LKH-Medizinische Universitatsklinik Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Nuhr Zentrum
City
Senftenberg
ZIP/Postal Code
3541
Country
Austria
Facility Name
ClinPharm International GmbH
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Medizinische Universitaet Wien/AKH
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Rheuma Zentrum Favoriten
City
Wien
ZIP/Postal Code
A-1100
Country
Austria
Facility Name
CHU de Nantes
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Viereck-Apotheke
City
Berlin-Buch
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charité-Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinische Forschung Berlin-Buch GmbH
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Apotheke
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Herz Apotheke
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus ClinPharm GmbH
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus ClinParm GmbH
City
Dresden
ZIP/Postal Code
01067
Country
Germany
Facility Name
Apotheke im Arztehaus Mickten
City
Dresden
ZIP/Postal Code
01127
Country
Germany
Facility Name
Schiller Apotheke & Stadt Apotheke
City
Goeppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Schmerz- und Palliativzentrum Goeppingen
City
Goeppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Falken Apotheke Hoheluft
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hamburg GmbH
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Klinische Forschung Hannover - Mitte GmbH
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Loewen-Apotheke
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Synexus ClinPharm GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Arkana Apotheke OHG
City
Leipzig
ZIP/Postal Code
04315
Country
Germany
Facility Name
Synexus ClinPharm GmbH
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Apotheke im MSZ
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Apotheke des Ernst von Bergmann Klinikums
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Synexus ClinParm GmbH
City
Potsdam
ZIP/Postal Code
14467
Country
Germany
Facility Name
Kirchsteig Apotheke
City
Potsdam
ZIP/Postal Code
14480
Country
Germany
Facility Name
"Centrum Medyczne MEDENS S.C. Niepubliczny Zaklad
City
Chelm Slaski
ZIP/Postal Code
41-403
Country
Poland
Facility Name
Malopolskie Centrum Medyczne s.c.
City
Krakow
ZIP/Postal Code
31-510
Country
Poland
Facility Name
Centrum Medyczne OSTEOMED Sp. z o. o.
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Synexus SCM Sp. z o.o.
City
Wroclaw
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej "POLIMEDICA"
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
Municipal Hospital No. 1 "Schuller"
City
Ploiesti
State/Province
District Prahova
ZIP/Postal Code
100337
Country
Romania
Facility Name
Clinical Emergency Military Hospital "Dr. Carol Davila"
City
Bucharest
ZIP/Postal Code
010225
Country
Romania
Facility Name
Duo Medical srl
City
Bucharest
ZIP/Postal Code
010584
Country
Romania
Facility Name
Medical Center "SANA"
City
Bucharest
ZIP/Postal Code
011025
Country
Romania
Facility Name
Clinical Hospital "Sf. Maria"
City
Bucharest
ZIP/Postal Code
011172
Country
Romania
Facility Name
Center of Rheumatology "Dr Ion Stoia"
City
Bucharest
ZIP/Postal Code
020985
Country
Romania
Facility Name
Clinical Emergency County Hospital Constanta
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
County Emergency Clinic Hospital "Sf. Apostol Andrei"
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Center polyclinic of Federal State Institution
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
State Healthcare Institution of Moscow city "City Clinical Hospital #15 n.a. O. M. Filatov"
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Chair of Hospital Therapy of Ryazan State Medical University
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Hospital #25 City Rheumatology Center"
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
State Educational Institution of Additional Professional Education
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Institution of Russian Academy of Sciences "St. Petersburg Clinical Hospital of RAS"
City
St. Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Outpatient Clinical #51"
City
St. Petersburg
ZIP/Postal Code
196211
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City Pokrovskaya Hospital"
City
St. Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
Facility Name
Hospital Nuestra Señora de la Esperanza
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15705
Country
Spain
Facility Name
Centro Salud Petrer 1
City
Petrer
State/Province
Alicante
ZIP/Postal Code
03610
Country
Spain
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Comarcal de Elda
City
Elda Alicante
ZIP/Postal Code
03600
Country
Spain
Facility Name
Hospital Universitario Getafe
City
Getafe-Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hospital G. U. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Clinico Universitario Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Me3plus AB
City
Goteborg
ZIP/Postal Code
400 14
Country
Sweden
Facility Name
Me3plus AB
City
Goteborg
ZIP/Postal Code
412 63
Country
Sweden
Facility Name
Center for Lakemedelsstudier
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Medicinskt Centrum
City
Norrkoping
ZIP/Postal Code
602 32
Country
Sweden
Facility Name
Chernivtsi Regional Clinical Hospital,Department of Rheumatology
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Road Clinical Hospital at Dnipropetrovsk station, Department of Rheumatology
City
Dnipropetrovsk
ZIP/Postal Code
49008
Country
Ukraine
Facility Name
Institute of Urgent and Recovery Surgery named after V.K. Gusaka AMS Ukraine
City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
Central City Clinical Hospital#1, Department of Therapy,
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Ivano-Frankivsk Regional Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
City Clinical Hospital #8, Department of reumatology,
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Facility Name
State Institution "Institute of Gerontology AMS of Ukraine"
City
Kiev
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Oleksandrivska Clinical Hospital in Kyiv-Department of Rheumatology # 1
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Kyiv Central Basin Clinical Hospital, Department of cardiology,
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
4th City Communal Clinical Hospital, Department of Rheumatology,
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
City communal clinical hospital #5, Dept. of Therapy, Danylo Galytskiy Lviv National Med. University
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Communal Institution Ternopil regional council, "Ternopil Regional Clinical Hospital"
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Facility Name
Vinnytsya regional clinical hospital named after M.I. Pyrogova
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Communal institution "City Hospital #7", Department of Therapy,
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine
Facility Name
Barnsley Hospital NHS Trust
City
Barnsley
State/Province
South Yorkshire
ZIP/Postal Code
S75 2EP
Country
United Kingdom
Facility Name
Department of Rheumatology
City
Dudley, West Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Wrightington Hospital
City
Wigan
ZIP/Postal Code
WN6 9EP
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
30936738
Citation
Tive L, Bello AE, Radin D, Schnitzer TJ, Nguyen H, Brown MT, West CR. Pooled analysis of tanezumab efficacy and safety with subgroup analyses of phase III clinical trials in patients with osteoarthritis pain of the knee or hip. J Pain Res. 2019 Mar 19;12:975-995. doi: 10.2147/JPR.S191297. eCollection 2019. Erratum In: J Pain Res. 2020 Sep 14;13:2267-2268.
Results Reference
derived
PubMed Identifier
26554876
Citation
Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492.
Results Reference
derived
PubMed Identifier
23852695
Citation
Balanescu AR, Feist E, Wolfram G, Davignon I, Smith MD, Brown MT, West CR. Efficacy and safety of tanezumab added on to diclofenac sustained release in patients with knee or hip osteoarthritis: a double-blind, placebo-controlled, parallel-group, multicentre phase III randomised clinical trial. Ann Rheum Dis. 2014 Sep;73(9):1665-72. doi: 10.1136/annrheumdis-2012-203164. Epub 2013 Jul 12.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091017&StudyName=Analgesic%20Efficacy%20And%20Safety%20of%20Tanezumab%20Added%20On%20To%20Diclofenac%20SR%20In%20Patients%20With%20Osteoarthritis%20Of%20The%20Knee%20Or%20Hip
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Analgesic Efficacy And Safety of Tanezumab Added On To Diclofenac SR In Patients With Osteoarthritis Of The Knee Or Hip

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