Tanezumab In Osteoarthritis Of The Knee (2)
A PHASE 3 RANDOMIZED, DOUBLE BLIND PLACEBO AND NAPROXEN CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
2 other identifiers
interventional
832
1 country
94
Brief Summary
The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2009
Shorter than P25 for phase_3
94 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
January 23, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedStudy Start
First participant enrolled
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2010
CompletedResults Posted
Study results publicly available
May 13, 2021
CompletedMay 13, 2021
April 1, 2021
1 year
January 23, 2009
April 20, 2021
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions scored on a numerical rating scale of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain. An overall possible WOMAC pain subscale score range is of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
Baseline (Day 1), Week 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
WOMAC: self-administered, disease-specific questionnaire which assesses clinically important, participant-relevant symptoms in participants with osteoarthritis of knee. WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee joint during past 48 hours. It is calculated as mean of the scores from 17 individual questions scored on a numerical rating scale of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicate more difficulty. An overall possible WOMAC physical function subscale score range is of 0 (minimum difficulty) to 10 (maximum difficulty), 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 of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
Participants answered: "Considering all the ways the osteoarthritis in your index knee affects you, how are you doing today?" Participants responded on the scale ranging from 1 (minimum affected) to 5 (maximum affected), where 1= very good, 2= good, 3= fair, 4= poor and 5= very poor. Higher scores indicate worse condition.
Baseline, Week 16
Secondary Outcomes (30)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Week 2, 4, 8, 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Baseline, Week 2, 4, 8, 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Week 2, 4, 8, 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
Baseline, Week 2, 4, 8, 12
Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Week 2, 4, 8, 12
- +25 more secondary outcomes
Other Outcomes (6)
Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
Day 1 (Baseline) up to Week 24
Number of Participants With Laboratory Test Abnormalities
Day 1 (Baseline) up to Week 24
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
Day 1 (Baseline) up to Week 24
- +3 more other outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATOR4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the knee according to Kellgren-Lawrence x-ray grade of 2
You may not qualify if:
- Pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurologic or cardiac disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (94)
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Pinnaccle Research Group, LLC
Anniston, Alabama, 36207, United States
Clinical Research Advantage, Inc. / Mesa Family Medical Center, PC
Mesa, Arizona, 85203, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Paradise Valley, Arizona, 85253, United States
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Arizona Research Center
Phoenix, Arizona, 85023, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, 85037, United States
University of Arizona - Arizona Arthritis Center
Tucson, Arizona, 85724, United States
University of Arizona
Tucson, Arizona, 85724, United States
St. Joseph's Mercy Clinic
Hot Springs, Arkansas, 71913, United States
Osteoporosis Medical Center
Beverly Hills, California, 90211, United States
Valley Research
Fresno, California, 93720, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Lawrence P McAdam, MD / A Medical Corporation
Thousand Oaks, California, 91360, 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
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Avail Clinical Research, LLC
DeLand, Florida, 32720, 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
Kendall South Medical Center, Inc
Miami, Florida, 33175, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, 33321, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, 30342, United States
Jeffrey D. Lieberman, MD
Decatur, Georgia, 30033, United States
Marietta Rheumatology
Marietta, Georgia, 30060, United States
Physician Pain Care
Woodstock, Georgia, 30188, 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
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
Koch Family Practice
Morton, Illinois, 61550, United States
Illinois Bone and Joint Institute, LLC
Morton Grove, Illinois, 60053, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
David H. Neustadt, PSC
Louisville, Kentucky, 40202, United States
Stanocola Medical Center
Baton Rouge, Louisiana, 70816, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, 21702, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Shores Rheumatology, P.C.
Saint Clair Shores, Michigan, 48081, United States
MAPS Applied Research Center, Inc
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
G. Timothy Kelly, MD
Las Vegas, Nevada, 89128, United States
Michael Clifford, 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
The Medical Research Network, LLC
New York, New York, 10024, United States
AAIR Research Center
Rochester, New York, 14618, United States
Andrew J. Porges, MD, PC
Roslyn, New York, 11576, United States
Carolina Bone and Joint, PA
Charlotte, North Carolina, 28210, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, 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 Incorporated
Zanesville, Ohio, 43701, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Appalachian Medical Research, Inc
Johnson City, Tennessee, 37604, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Capitol Medical Clinic
Austin, Texas, 78705, United States
Office of Walter F Chase, MD, PA
Austin, Texas, 78705, United States
North Texas Joint Care, PA
Dallas, Texas, 75230, United States
Asif Cochinwala, MD, PA
Houston, Texas, 77008, United States
Pioneer Research Solutions, Inc
Houston, Texas, 77036, United States
Radiant Research San Antonio Northeast
San Antonio, Texas, 78217, United States
Diagnostic Research Group
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
South Texas Radiology Group
San Antonio, Texas, 78229, United States
Aspen Clinical Research, LLC
Orem, Utah, 84058, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
Arthritis and Rheumatic Diseases
Portsmouth, Virginia, 23701, United States
Clinical Trials Northwest
Yakima, Washington, 98902, United States
Related Publications (3)
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: 30936738DERIVEDEkman EF, Gimbel JS, Bello AE, Smith MD, Keller DS, Annis KM, Brown MT, West CR, Verburg KM. Efficacy and safety of intravenous tanezumab for the symptomatic treatment of osteoarthritis: 2 randomized controlled trials versus naproxen. J Rheumatol. 2014 Nov;41(11):2249-59. doi: 10.3899/jrheum.131294. Epub 2014 Oct 1.
PMID: 25274899DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2009
First Posted
January 27, 2009
Study Start
May 5, 2009
Primary Completion
May 17, 2010
Study Completion
August 31, 2010
Last Updated
May 13, 2021
Results First Posted
May 13, 2021
Record last verified: 2021-04
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.