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Tanezumab in Osteoarthritis Of The Hip

Primary Purpose

Arthritis, Osteoarthritis, Osteoarthritis, Hip

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

About this trial

This is an interventional treatment trial for Arthritis focused on measuring monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA

Eligibility Criteria

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

Inclusion Criteria:

  • Osteoarthritis of the hip according to ACR criteria with Kellgren-Lawrence x-ray grade of 2
  • Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for Hip injections, arthroplasty or replacement surgery
  • Pain level and function levels as required by the protocol at Screening and Baseline
  • Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study
  • Must agree to the contraceptive requirements of the protocol if applicable
  • Must agree to the treatment plan, scheduled visits, and procedures of the protocol

Exclusion Criteria:

  • Pregnancy
  • BMI greater than 39
  • Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Sites / Locations

  • Horizon Research Group
  • Arizona Arthritis & Rheumatology Associates, PC
  • Pivotal Research Center
  • Arizona Research Center, Inc.
  • Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC
  • Arizona Arthritis & Rheumatology Associates, PC
  • Quality of Life Medical & Research Center, LLC
  • Quality of Life Medical and Research Center
  • Tucson Orthopaedic Institute
  • St. Joseph's Mercy Clinic
  • Providence Clinical Research
  • Arthritis Medical Clinic of North County, Inc.
  • Talbert Medical Group
  • Trinity Clinical Trials
  • Clinical Research Center of Connecticut
  • Stamford Therapeutics Consortium
  • Javed Rheumatology Associates, Inc.
  • Innovative Research of West Florida, Inc.
  • Tampa Bay Medical Research Inc
  • Avail Clinical Research, LLC
  • Avail Clinical Research
  • Arthritis Associates of South Florida
  • Delray Research Associates
  • Westside Center for Clinical Research
  • Adult Medicine Specialists
  • Genesis Research International
  • International Research Associates, LLC
  • Compass Research, LLC
  • The Arthritis Center
  • Advent Clinical Research Centers
  • Avivoclin Clinical Services
  • Accord Clinical Research, LLC
  • All Florida Orthopaedic Associates
  • Palm Beach Research Center
  • Arthritis and Rheumatology of Georgia
  • Laureate Clinical Reseach Group
  • Early Family Practice Center
  • Northeast Georgia Diagnostic Clinic
  • North Georgia Clinical Research
  • North Georgia Clinical Research
  • North Georgia Internal medicine
  • Sonora Clinical Research
  • The Arthritis Center
  • American Health Network of IN, LLC
  • Northwest Indiana Center for Clinical Research
  • Arthritis and Diabetes Clinic
  • Maine Research Associates
  • The Arthritis and Osteoporosis Center of Maryland
  • The Center for Rheumatology and Bone Research
  • Mansfield Health Center
  • Clinical Pharmacology Study Group
  • Ann Arbor Clinical Research
  • Rheumatology, PC
  • MAPS Applied Research Center
  • Medical Advanced Pain Specialists
  • Mercy Health Research
  • Quality Clinical Research, Inc.
  • Clinical Research Consortium
  • Mirkil Medical
  • Office of Dr. Danka Michaels, MD
  • Comprehensive Clinical Research
  • Albuquerque Clinical Trials, Inc.
  • New Mexico Clinical Research & Osteoporosis Center, Incorporated
  • Arthritis and Osteoporosis Center of Brooklyn Heights
  • The Medical Research Network, LLC
  • Prem C. Chatpar, MD, LLC
  • Office of Dr. Andrew Porges
  • Carolina Bone & Joint, P.A.
  • Pharmquest
  • Piedmont Medical Research Associates
  • Consultants for Clinical Research/Ohio GI and Liver Institute
  • Hilltop Physicians Inc, Hightop Medical Research Center
  • Southwest Rheumatology and Research Group, LLC
  • Pharmacotherapy Research Associates,Inc
  • Health Research Institute
  • EPIC Imaging West
  • EPIC Imaging East
  • Covance CRU, Inc.
  • East Penn Rheumatology Associates, PC
  • Brandywine Clinical Research
  • Altoona Center for Clinical Research
  • Health Concepts
  • Appalachian Medical Research Inc.
  • Holston Medical Group
  • Capital Medical Clinic
  • Walter Chase MD
  • Radiant Research
  • Rheumatic Disease Clinical Research Center
  • Pioneer Research Solutions
  • Pioneet Research Solutions, Inc
  • Clinical Investigations of Texas, LLC
  • Radiant Research San Antonio NE
  • Texas Arthritis Research Center, PA
  • Diagnostics Research Group
  • Sushma V. Gorrela, MD
  • Optimum Clinical Research
  • Charlottesville Medical Research
  • Internal Medicine Northwest, Frank S Baker Center
  • Clinical Trials Northwest

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tanezumab 10 mg

Tanezumab 5 mg

Tanezumab 2.5 mg

Placebo

Arm Description

Tanezumab 10 mg IV every 8 weeks

Tanezumab 5mg IV every 8 weeks

Tanezumab 2.5 mg IV every 8 weeks.

Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 at Week 16: Baseline Observation Carried Forward (BOCF)
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.

Secondary Outcome Measures

Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response.
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain.
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = worst possible pain, where higher scores indicating higher pain.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning.
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 domains were also summarized as summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for the each summary scores =0 to 100, where higher scores represented higher level of functioning. Higher summary scores indicated a better health related quality of life.
Time to Discontinuation Due to Lack of Efficacy
Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.
Percentage of Participants Who Used Rescue Medication
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the particular study week were summarized.
Duration of Rescue Medication Use
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participant used any of the rescue medication, during the specified week were summarized.
Amount of Rescue Medication Taken
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 Week 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events.
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24
The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment.

Full Information

First Posted
August 29, 2008
Last Updated
February 8, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00744471
Brief Title
Tanezumab in Osteoarthritis Of The Hip
Official Title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 17, 2008 (Actual)
Primary Completion Date
March 15, 2010 (Actual)
Study Completion Date
August 13, 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 test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Osteoarthritis, Osteoarthritis, Hip
Keywords
monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tanezumab 10 mg
Arm Type
Experimental
Arm Description
Tanezumab 10 mg IV every 8 weeks
Arm Title
Tanezumab 5 mg
Arm Type
Experimental
Arm Description
Tanezumab 5mg IV every 8 weeks
Arm Title
Tanezumab 2.5 mg
Arm Type
Experimental
Arm Description
Tanezumab 2.5 mg IV every 8 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
Tanezumab 10 mg IV every 8 weeks
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
Tanezumab 5mg IV every 8 weeks
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
Tanezumab 2.5 mg IV every 8 weeks.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo to match tanezumab IV every 8 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame
Baseline (Day 1), Week 16
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 at Week 16: Baseline Observation Carried Forward (BOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame
Baseline, Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 2, 4, 8, 12, 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Physical function refers to participant's ability to move around and perform usual activities of daily living.
Time Frame
Baseline, Week 2, 4, 8, 12, 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (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. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a NRS of 0 to 10, where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 to 10, 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 2, 4, 8, 12, 16, 24
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame
Baseline, Week 2, 4, 8, 12, 24
Title
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your hip joint affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good (no symptom and limitation of normal activities) and 5 = very poor (very severe symptoms and inability to carry out normal activities), where lower scores indicates better condition.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
Description
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Time Frame
Week 2, 4, 8, 12, 16, 24
Title
Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
Description
A participant was considered as an OMERACT-OARSI responder if at least one of the following criteria were met: Improvement in WOMAC pain or physical function subscale from baseline to week of interest was greater than or equal to (>=) 50 percent (%)and absolute change of >=2 units from baseline at the week of interest, or at least 2 of the following 3 being true: >=20% improvement from baseline and absolute change from baseline of >=1 unit at the week of interest in 1) WOMAC pain subscale, 2) WOMAC physical function subscale, 3) PGA of osteoarthritis. Score range for PGA: 1 = very good to 5 = very poor, where higher scores=more affected). WOMAC pain, physical function subscales assess amount of pain/difficulty experienced (score: 0 [no pain] to 10 [worst possible pain], higher score=higher pain/difficulty).
Time Frame
Week 2, 4, 8, 12 ,16, 24
Title
Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Percentage of participants with >=30% or >=50% reduction in WOMAC pain subscale score from baseline to specified weeks were reported.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Time Frame
Baseline, Week 2, 4, 8, 12 ,16, 24
Title
Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)
Description
Participants answered: "Considering all the ways your osteoarthritis in your knee affects you, how are you doing today?", participants responded by using a 5-point scale where 1 = very good and 5 = very poor where lower scores indicating better condition. Percentage of participants with an improvement of greater than or equal to 2 points from baseline at specified weeks were reported.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
Time Frame
Baseline, Week 16
Title
Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (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. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a NRS of 0 to 10, where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 to 10, where higher scores indicate higher pain. Participants with specified reduction (as percent) from baseline at Week 16 were reported.
Time Frame
Baseline, Week 16
Title
Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
Description
Participants assessed daily average hip joint pain during the past 24 hours on an 11-point NRS ranging from 0 (no pain) to 10 (worst pain). Post baseline weekly scores were calculated as the mean of the scores over the last 7 days prior to each assessment time point.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC stiffness subscale is a 2-item questionnaire used to assess the amount of stiffness experienced due to osteoarthritis in hip joint during past 48 hours. It is calculated as mean of the scores from 2 individual questions each scored on numerical rating scale of 0 (minimum stiffness) to 10 (maximum stiffness), giving an overall possible mean score range of 0 (minimum stiffness) to 10 (maximum stiffness). Higher scores indicate higher stiffness. Stiffness is defined as a sensation of decreased ease in movement of hip joint.
Time Frame
Baseline, Week 2, 4, 8, 12 ,16, 24
Title
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. WOMAC: self-administered, disease-specific 24-item questionnaire which assesses clinically important, participant-relevant symptoms for pain (5 items), stiffness (2 items) and physical function (17 items) in participants with osteoarthritis of hip joint. Each item is scored on a 0 (no pain) to 10 (worst possible pain) NRS scale, where higher scores indicate higher pain/stiffness or worse function. WOMAC average score is the mean of WOMAC pain, physical function and stiffness subscale scores and ranges from 0 (no pain) to 10 (worst possible pain), where higher score indicates worse response.
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 Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when walking on a flat surface?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 =extreme pain. Higher scores indicated more pain.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
Description
WOMAC: Self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms for pain, stiffness and physical function in participants with osteoarthritis. Participants answered "How much pain have you had when going up or down the stairs?". Participants responded by using a NRS of 0 to 10, where 0 = no pain and 10 = worst possible pain, where higher scores indicating higher pain.
Time Frame
Baseline, Week 2, 4, 8, 12, 16, 24
Title
Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
Description
The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning.
Time Frame
Baseline, Week 12, 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: Baseline Observation Carried Forward (BOCF)
Description
The SF-36 health survey was a self-administered questionnaire that measures each of the following 8 health domains: domain 1= general health, domain 2= physical function, domain 3= role physical, domain 4= bodily pain, domain 5= vitality, domain 6= social function, domain 7= role emotional, domain 8= mental health. Total score for each domain are scaled 0 (minimum) to 100 (maximum), where higher score indicates highest level of functioning. These 8 domains were also summarized as summary scores: mental component aggregate (MCA) and physical component aggregate (PCA). Total score range for the each summary scores =0 to 100, where higher scores represented higher level of functioning. Higher summary scores indicated a better health related quality of life.
Time Frame
Baseline, Week 12, 24
Title
Time to Discontinuation 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
Title
Percentage of Participants Who Used Rescue Medication
Description
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Percentage of participants with any use of rescue medication during the particular study week were summarized.
Time Frame
Week 2, 4, 8, 12 ,16, 24
Title
Duration of Rescue Medication Use
Description
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. Number of days participant used any of the rescue medication, during the specified week were summarized.
Time Frame
Week 2, 4, 8, 12, 16, 24
Title
Amount of Rescue Medication Taken
Description
In case of inadequate pain relief for osteoarthritis, acetaminophen up to 4000 mg per day up to 3 days per week could be taken as rescue medication. The total dosage of acetaminophen in mg used during the specified week were summarized.
Time Frame
Week 2, 4, 8, 12, 16, 24
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 Week 32 that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and all non-serious adverse events.
Time Frame
Baseline up to Week 32
Title
Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24
Description
The NIS is a standardized instrument used to evaluate participant for signs of peripheral neuropathy. Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS is the sum of scores of over all 37 items (24 scored 0-4; 13 scored 0-2), made separately for left and right sides, giving a possible overall score range of 0 (no impairment) to 122 (severe impairment). NIS Total score range (total of both left and right sides) was 0 (no impairment) to 244 (severe impairment), where higher scores indicated increased impairment.
Time Frame
Baseline, Week 2, 4, 6, 8, 12, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritis of the hip according to ACR criteria with Kellgren-Lawrence x-ray grade of 2 Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for Hip injections, arthroplasty or replacement surgery Pain level and function levels as required by the protocol at Screening and Baseline Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study Must agree to the contraceptive requirements of the protocol if applicable Must agree to the treatment plan, scheduled visits, and procedures of the protocol Exclusion Criteria: Pregnancy BMI greater than 39 Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
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
Horizon Research Group
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, PC
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Pivotal Research Center
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Arizona Research Center, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates, PC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Quality of Life Medical & Research Center, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Quality of Life Medical and Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
St. Joseph's Mercy Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Arthritis Medical Clinic of North County, Inc.
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Talbert Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Trinity Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Clinical Research Center of Connecticut
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Javed Rheumatology Associates, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Tampa Bay Medical Research Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Avail Clinical Research, LLC
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Arthritis Associates of South Florida
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Westside Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Adult Medicine Specialists
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Genesis Research International
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Compass Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Advent Clinical Research Centers
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Avivoclin Clinical Services
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Accord Clinical Research, LLC
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
All Florida Orthopaedic Associates
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Arthritis and Rheumatology of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Laureate Clinical Reseach Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Early Family Practice Center
City
Fort Valley
State/Province
Georgia
ZIP/Postal Code
31030
Country
United States
Facility Name
Northeast Georgia Diagnostic Clinic
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
North Georgia Clinical Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
North Georgia Internal medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Sonora Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
American Health Network of IN, LLC
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46038
Country
United States
Facility Name
Northwest Indiana Center for Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Maine Research Associates
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
The Arthritis and Osteoporosis Center of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
The Center for Rheumatology and Bone Research
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Mansfield Health Center
City
Mansfield
State/Province
Massachusetts
ZIP/Postal Code
02048
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Ann Arbor Clinical Research
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Rheumatology, PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
MAPS Applied Research Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Medical Advanced Pain Specialists
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy Health Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Quality Clinical Research, Inc.
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Mirkil Medical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Office of Dr. Danka Michaels, MD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
New Mexico Clinical Research & Osteoporosis Center, Incorporated
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Arthritis and Osteoporosis Center of Brooklyn Heights
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Prem C. Chatpar, MD, LLC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Office of Dr. Andrew Porges
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576-1507
Country
United States
Facility Name
Carolina Bone & Joint, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Pharmquest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Piedmont Medical Research Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research/Ohio GI and Liver Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Hilltop Physicians Inc, Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Southwest Rheumatology and Research Group, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Pharmacotherapy Research Associates,Inc
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
EPIC Imaging West
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97008
Country
United States
Facility Name
EPIC Imaging East
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Covance CRU, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
East Penn Rheumatology Associates, PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Brandywine Clinical Research
City
Downingtown
State/Province
Pennsylvania
ZIP/Postal Code
19335-2620
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Appalachian Medical Research Inc.
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604-1417
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Capital Medical Clinic
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Walter Chase MD
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Rheumatic Disease Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Pioneer Research Solutions
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Pioneet Research Solutions, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77036
Country
United States
Facility Name
Clinical Investigations of Texas, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Radiant Research San Antonio NE
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Arthritis Research Center, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sushma V. Gorrela, MD
City
Spring
State/Province
Texas
ZIP/Postal Code
77379
Country
United States
Facility Name
Optimum Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Internal Medicine Northwest, Frank S Baker Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-4260
Country
United States
Facility Name
Clinical Trials Northwest
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
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
23553790
Citation
Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis Rheum. 2013 Jul;65(7):1795-803. doi: 10.1002/art.37950.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091014&StudyName=Tanezumab%20in%20Osteoarthritis%20Of%20The%20Hip
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Tanezumab in Osteoarthritis Of The Hip

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