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.
2 other identifiers
interventional
627
1 country
99
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2008
99 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 1, 2008
CompletedStudy Start
First participant enrolled
November 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 13, 2010
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
February 1, 2021
1.3 years
August 29, 2008
February 8, 2021
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (27)
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)
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)
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)
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)
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)
Baseline, Week 2, 4, 8, 12, 24
- +22 more secondary outcomes
Study Arms (4)
Tanezumab 10 mg
EXPERIMENTALTanezumab 10 mg IV every 8 weeks
Tanezumab 5 mg
EXPERIMENTALTanezumab 5mg IV every 8 weeks
Tanezumab 2.5 mg
EXPERIMENTALTanezumab 2.5 mg IV every 8 weeks.
Placebo
EXPERIMENTALPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (99)
Horizon Research Group
Mobile, Alabama, 36608, United States
Arizona Arthritis & Rheumatology Associates, PC
Paradise Valley, Arizona, 85253, United States
Pivotal Research Center
Peoria, Arizona, 85381, United States
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC
Phoenix, Arizona, 85028, United States
Arizona Arthritis & Rheumatology Associates, PC
Phoenix, Arizona, 85037, United States
Quality of Life Medical & Research Center, LLC
Tucson, Arizona, 85712, United States
Quality of Life Medical and Research Center
Tucson, Arizona, 85712, United States
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
St. Joseph's Mercy Clinic
Hot Springs, Arkansas, 71913, United States
Providence Clinical Research
Burbank, California, 91505, United States
Arthritis Medical Clinic of North County, Inc.
Escondido, California, 92025, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
Trinity Clinical Trials
Santa Ana, California, 92701, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Javed Rheumatology Associates, Inc.
Newark, Delaware, 19713, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Tampa Bay Medical Research Inc
Clearwater, Florida, 33761, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Arthritis Associates of South Florida
Delray Beach, Florida, 33484, United States
Delray Research Associates
Delray Beach, Florida, 33484, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Adult Medicine Specialists
Longwood, Florida, 32779, United States
Genesis Research International
Longwood, Florida, 32779, United States
International Research Associates, LLC
Miami, Florida, 33183, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
Advent Clinical Research Centers
Pinellas Park, Florida, 33781, United States
Avivoclin Clinical Services
Port Orange, Florida, 32127, United States
Accord Clinical Research, LLC
Port Orange, Florida, 32129, United States
All Florida Orthopaedic Associates
St. Petersburg, Florida, 33703, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
Laureate Clinical Reseach Group
Atlanta, Georgia, 30342, United States
Early Family Practice Center
Fort Valley, Georgia, 31030, United States
Northeast Georgia Diagnostic Clinic
Gainesville, Georgia, 30501, United States
North Georgia Clinical Research
Marietta, Georgia, 30060, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal medicine
Woodstock, Georgia, 30189, United States
Sonora Clinical Research
Boise, Idaho, 83702, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
American Health Network of IN, LLC
Fishers, Indiana, 46038, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
Maine Research Associates
Auburn, Maine, 04210, United States
The Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Mansfield Health Center
Mansfield, Massachusetts, 02048, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Ann Arbor Clinical Research
Ann Arbor, Michigan, 48103, United States
Rheumatology, PC
Kalamazoo, Michigan, 49009, United States
MAPS Applied Research Center
Edina, Minnesota, 55435, United States
Medical Advanced Pain Specialists
Edina, Minnesota, 55435, United States
Mercy Health Research
St Louis, Missouri, 63141, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Mirkil Medical
Las Vegas, Nevada, 89119, United States
Office of Dr. Danka Michaels, MD
Las Vegas, Nevada, 89128, United States
Comprehensive Clinical Research
Berlin, New Jersey, 08009, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
New Mexico Clinical Research & Osteoporosis Center, Incorporated
Albuquerque, New Mexico, 87106, United States
Arthritis and Osteoporosis Center of Brooklyn Heights
Brooklyn, New York, 11201, United States
The Medical Research Network, LLC
New York, New York, 10128, United States
Prem C. Chatpar, MD, LLC
Plainview, New York, 11803, United States
Office of Dr. Andrew Porges
Roslyn, New York, 11576-1507, United States
Carolina Bone & Joint, P.A.
Charlotte, North Carolina, 28210, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research/Ohio GI and Liver Institute
Cincinnati, Ohio, 45219, United States
Hilltop Physicians Inc, Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
Southwest Rheumatology and Research Group, LLC
Middleburg Heights, Ohio, 44130, United States
Pharmacotherapy Research Associates,Inc
Zanesville, Ohio, 43701, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
EPIC Imaging West
Beaverton, Oregon, 97008, United States
EPIC Imaging East
Portland, Oregon, 97220, United States
Covance CRU, Inc.
Portland, Oregon, 97239, United States
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, 18015, United States
Brandywine Clinical Research
Downingtown, Pennsylvania, 19335-2620, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Appalachian Medical Research Inc.
Johnson City, Tennessee, 37604-1417, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Capital Medical Clinic
Austin, Texas, 78705, United States
Walter Chase MD
Austin, Texas, 78705, United States
Radiant Research
Dallas, Texas, 75231, United States
Rheumatic Disease Clinical Research Center
Houston, Texas, 77004, United States
Pioneer Research Solutions
Houston, Texas, 77008, United States
Pioneet Research Solutions, Inc
Houston, Texas, 77036, United States
Clinical Investigations of Texas, LLC
Plano, Texas, 75075, United States
Radiant Research San Antonio NE
San Antonio, Texas, 78217, United States
Texas Arthritis Research Center, PA
San Antonio, Texas, 78217, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Sushma V. Gorrela, MD
Spring, Texas, 77379, United States
Optimum Clinical Research
Salt Lake City, Utah, 84102, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Internal Medicine Northwest, Frank S Baker Center
Tacoma, Washington, 98405-4260, United States
Clinical Trials Northwest
Yakima, Washington, 98902, United States
Related Publications (4)
Brown MT, Cornblath DR, Koltzenburg M, Gorson KC, Hickman A, Pixton GC, Gaitonde P, Viktrup L, West CR. Peripheral Nerve Safety of Nerve Growth Factor Inhibition by Tanezumab: Pooled Analyses of Phase III Clinical Studies in Over 5000 Patients with Osteoarthritis. Clin Drug Investig. 2023 Jul;43(7):551-563. doi: 10.1007/s40261-023-01286-3. Epub 2023 Jul 18.
PMID: 37460782DERIVEDTive 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.
PMID: 30936738DERIVEDHochberg 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.
PMID: 26554876DERIVEDBrown 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.
PMID: 23553790DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 1, 2008
Study Start
November 17, 2008
Primary Completion
March 15, 2010
Study Completion
August 13, 2010
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
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.