Tanezumab in Osteoarthritis Of The Hip

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.

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients

Study Overview

• Status: Completed
• Conditions: Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Intervention / Treatment: Biological: tanezumab; Biological: tanezumab; Biological: tanezumab; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 627
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Horizon Research Group
  • Arizona
    • Paradise Valley, Arizona, United States, 85253
      • Arizona Arthritis & Rheumatology Associates, PC
    • Peoria, Arizona, United States, 85381
      • Pivotal Research Center
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center, Inc.
    • Phoenix, Arizona, United States, 85028
      • Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates, PC
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical & Research Center, LLC
    • Tucson, Arizona, United States, 85712
      • Quality of Life Medical and Research Center
    • Tucson, Arizona, United States, 85712
      • Tucson Orthopaedic Institute
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • St. Joseph'S Mercy Clinic
  • California
    • Burbank, California, United States, 91505
      • Providence Clinical Research
    • Escondido, California, United States, 92025
      • Arthritis Medical Clinic of North County, Inc.
    • Huntington Beach, California, United States, 92646
      • Talbert Medical Group
    • Santa Ana, California, United States, 92701
      • Trinity Clinical Trials
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Clinical Research Center of Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Therapeutics Consortium
  • Delaware
    • Newark, Delaware, United States, 19713
      • Javed Rheumatology Associates, Inc.
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research Of West Florida, Inc.
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research Inc
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research, LLC
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Delray Beach, Florida, United States, 33484
      • Arthritis Associates of South Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Research Associates
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
    • Longwood, Florida, United States, 32779
      • Adult Medicine Specialists
    • Longwood, Florida, United States, 32779
      • Genesis Research International
    • Miami, Florida, United States, 33183
      • International Research Associates, LLC
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Palm Harbor, Florida, United States, 34684
      • The Arthritis Center
    • Pinellas Park, Florida, United States, 33781
      • Advent Clinical Research Centers
    • Port Orange, Florida, United States, 32127
      • AvivoClin Clinical Services
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Saint Petersburg, Florida, United States, 33703
      • All Florida Orthopaedic Associates
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Arthritis and Rheumatology of Georgia
    • Atlanta, Georgia, United States, 30342
      • Laureate Clinical Reseach Group
    • Fort Valley, Georgia, United States, 31030
      • Early Family Practice Center
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Diagnostic Clinic
    • Marietta, Georgia, United States, 30060
      • North Georgia Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Georgia Clinical Research
    • Woodstock, Georgia, United States, 30189
      • North Georgia Internal Medicine
  • Idaho
    • Boise, Idaho, United States, 83702
      • Sonora Clinical Research
  • Illinois
    • Springfield, Illinois, United States, 62704
      • The Arthritis Center
  • Indiana
    • Fishers, Indiana, United States, 46038
      • American Health Network of IN, LLC
    • Valparaiso, Indiana, United States, 46383
      • Northwest Indiana Center for Clinical Research
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic
  • Maine
    • Auburn, Maine, United States, 04210
      • Maine Research Associates
  • Maryland
    • Frederick, Maryland, United States, 21702
      • The Arthritis and Osteoporosis Center of Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Massachusetts
    • Mansfield, Massachusetts, United States, 02048
      • Mansfield Health Center
    • Worcester, Massachusetts, United States, 01610
      • Clinical Pharmacology Study Group
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • Ann Arbor Clinical Research
    • Kalamazoo, Michigan, United States, 49009
      • Rheumatology, PC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • MAPS Applied Research Center
    • Edina, Minnesota, United States, 55435
      • Medical Advanced Pain Specialists
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Health Research
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Clinical Research Consortium
    • Las Vegas, Nevada, United States, 89119
      • Mirkil Medical
    • Las Vegas, Nevada, United States, 89128
      • Office of Dr. Danka Michaels, MD
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials, Inc.
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Clinical Research & Osteoporosis Center, Incorporated
  • New York
    • Brooklyn, New York, United States, 11201
      • Arthritis and Osteoporosis Center of Brooklyn Heights
    • New York, New York, United States, 10128
      • The Medical Research Network, LLC
    • Plainview, New York, United States, 11803
      • Prem C. Chatpar, MD, LLC
    • Roslyn, New York, United States, 11576-1507
      • Office of Dr. Andrew Porges
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Carolina Bone & Joint, P.A.
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest
    • Winston-Salem, North Carolina, United States, 27103
      • Piedmont Medical Research Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research/Ohio GI and Liver Institute
    • Cincinnati, Ohio, United States, 45224
      • Hilltop Physicians Inc, Hightop Medical Research Center
    • Middleburg Heights, Ohio, United States, 44130
      • Southwest Rheumatology and Research Group, LLC
    • Zanesville, Ohio, United States, 43701
      • Pharmacotherapy Research Associates,Inc
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Health Research Institute
  • Oregon
    • Beaverton, Oregon, United States, 97008
      • EPIC Imaging West
    • Portland, Oregon, United States, 97220
      • EPIC Imaging East
    • Portland, Oregon, United States, 97239
      • Covance Cru, Inc.
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • East Penn Rheumatology Associates, Pc
    • Downingtown, Pennsylvania, United States, 19335-2620
      • Brandywine Clinical Research
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Tennessee
    • Johnson City, Tennessee, United States, 37604-1417
      • Appalachian Medical Research Inc.
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Austin, Texas, United States, 78705
      • Capital Medical Clinic
    • Austin, Texas, United States, 78705
      • Walter Chase MD
    • Dallas, Texas, United States, 75231
      • Radiant Research
    • Houston, Texas, United States, 77004
      • Rheumatic Disease Clinical Research Center
    • Houston, Texas, United States, 77008
      • Pioneer Research Solutions
    • Houston, Texas, United States, 77036
      • Pioneet Research Solutions, Inc
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas, LLC
    • San Antonio, Texas, United States, 78217
      • Radiant Research San Antonio NE
    • San Antonio, Texas, United States, 78217
      • Texas Arthritis Research Center, PA
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • Spring, Texas, United States, 77379
      • Sushma V. Gorrela, MD
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • Optimum Clinical Research
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research
  • Washington
    • Tacoma, Washington, United States, 98405-4260
      • Internal Medicine Northwest, Frank S Baker Center
    • Yakima, Washington, United States, 98902
      • Clinical Trials Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tanezumab 10 mg; Tanezumab 10 mg IV every 8 weeks	Biological: tanezumab; Tanezumab 10 mg IV every 8 weeks; Biological: tanezumab; Tanezumab 5mg IV every 8 weeks; Biological: tanezumab; Tanezumab 2.5 mg IV every 8 weeks.
Experimental: Tanezumab 5 mg; Tanezumab 5mg IV every 8 weeks	Biological: tanezumab; Tanezumab 10 mg IV every 8 weeks; Biological: tanezumab; Tanezumab 5mg IV every 8 weeks; Biological: tanezumab; Tanezumab 2.5 mg IV every 8 weeks.
Experimental: Tanezumab 2.5 mg; Tanezumab 2.5 mg IV every 8 weeks.	Biological: tanezumab; Tanezumab 10 mg IV every 8 weeks; Biological: tanezumab; Tanezumab 5mg IV every 8 weeks; Biological: tanezumab; Tanezumab 2.5 mg IV every 8 weeks.
Experimental: Placebo	Biological: Placebo; Placebo to match tanezumab IV every 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 1), Week 16
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.	Baseline, Week 16
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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, 4, 8, 12, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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).	Week 2, 4, 8, 12, 16, 24
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).	Week 2, 4, 8, 12 ,16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12 ,16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 16
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.	Baseline, Week 16
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12 ,16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 2, 4, 8, 12, 16, 24
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.	Baseline, Week 12, 24
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.	Baseline, Week 12, 24
Time to Discontinuation Due to Lack of Efficacy	Median time to discontinuation due to lack of efficacy was estimated using Kaplan-Meier method.	Baseline up to Week 16
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.	Week 2, 4, 8, 12 ,16, 24
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.	Week 2, 4, 8, 12, 16, 24
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.	Week 2, 4, 8, 12, 16, 24
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.	Baseline up to Week 32
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.	Baseline, Week 2, 4, 6, 8, 12, 16, 24

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2008
• Primary Completion (Actual): March 15, 2010
• Study Completion (Actual): August 13, 2010

Study Registration Dates

• First Submitted: August 29, 2008
• First Submitted That Met QC Criteria: August 29, 2008
• First Posted (Estimate): September 1, 2008

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Tanezumab
• Other Study ID Numbers: A4091014; P3 OA HIP (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No