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Efficacy And Safety Study Of Tanezumab Subcutaneous Administration In Osteoarthritis - A Subcutaneous/Intravenous Bridging Study
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE.
2 other identifiers
interventional
385
1 country
91
Brief Summary
This is an efficacy and safety study of 3 doses (2.5 mg, 5 mg and 10mg) of tanezumab administered subcutaneously versus placebo. This study will also compare a subcutaneous (SC) administration of 10 mg of tanezumab) with an intravenous (IV) administration of 10 mg of tanezumab. Each person will receive an IV infusion and a SC infusion. The study will last 16 weeks for those who wish to enter a 64-week extension study or 24 weeks for those who do not.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
91 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
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 18, 2010
CompletedStudy Start
First participant enrolled
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2011
CompletedResults Posted
Study results publicly available
May 5, 2021
CompletedMay 5, 2021
February 1, 2021
7 months
March 11, 2010
April 9, 2021
April 9, 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
The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (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.
Baseline, Week 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 16
The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in the index joint in the past 48 hours. It is calculated as the mean of the scores from the 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.
Baseline, Week 16
Change From Baseline in Patient's Global Assessment (PGA) of Osteoarthritis Score at Week 16
Participants answered the question: "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 (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (severe symptoms and inability to carry out most normal activities) and 5 = very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
Baseline, Week 16
Secondary Outcomes (18)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 1, 2, 4, 8, and 12
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 1, 2, 4, 8, and 12
Baseline, Weeks 1, 2, 4, 8, and 12
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 1, 2, 4, 8, and 12
Baseline, Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
Weeks 1, 2, 4, 8, 12, and 16
Percentage of Participants With at Least 30%, 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Weeks 1, 2, 4, 8, 12, and 16
- +13 more secondary outcomes
Other Outcomes (11)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline up to 112 days after last dose of study treatment
Number of Participants With Abnormal Laboratory Findings
Day 1 up to Week 24
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Baseline up to Week 24
- +8 more other outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATOR2.5 mg tanezumab SC and placebo IV
EXPERIMENTAL5 mg tanezumab SC and placebo IV
EXPERIMENTAL10 mg tanezumab SC and placebo IV
EXPERIMENTAL10 mg tanezumab IV
EXPERIMENTALInterventions
1 ml tanezumab injection SC administered every 8 weeks
Eligibility Criteria
You may qualify if:
- Diagnosis of osteoarthritis (OA) of the knee according to American College of Rheumatology (ACR) criteria with a Kellgren- Lawrence score of greater than or equal to 2
- years of age or greater
- Two methods of birth control one of which must be barrier if of childbearing potential
- Willing to discontinue pain medication except as permitted per protocol
You may not qualify if:
- Pregnancy or wishing to be pregnant during the course of the study, lactating women
- Body Mass Index (BMI) greater than 39
- Clinically significant cardiac, neurological, psychiatric conditions and other conditions that are excluded by the protocol.
- Previous exposure to a Nerve Growth Factor (NGF) antibody
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (91)
Vaughn H. Mancha, Jr., MD, PC
Montgomery, Alabama, 36117, United States
Novara Clinical Research
Mesa, Arizona, 85206, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
West Coast Radiology Center
Anaheim, California, 92801, United States
Providence Clinical Research
Burbank, California, 91505, United States
Valley Research
Fresno, California, 93720, United States
Allergy and Rheumatology Medical Clinic, Inc.
La Jolla, California, 92037-1233, United States
Triwest Research Associates
La Mesa, California, 91942, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Benchmark Research
Sacramento, California, 95816, United States
Probe Clinical Research Corp.
Santa Ana, California, 92701, United States
Trinity Clinical Trials
Santa Ana, California, 92701, United States
FMC Clinical Trials
Upland, California, 91786, United States
Colorado Hematology
Englewood, Colorado, 80110, United States
Colorado Orthopedic Consultants, P.C.
Englewood, Colorado, 80110, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Office of Cynthia Morgan, MD
Washington D.C., District of Columbia, 20003, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
Nature Coast Clinical Research
Crystal River, Florida, 34429, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Westside Center for Clinical Research
Jacksonville, Florida, 32205, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
BayCare Outpatient Imaging at Bardmoor
Largo, Florida, 33777, United States
Sunshine Research Center
Opa-locka, Florida, 33054, United States
DMI Research, Inc.
Pinellas Park, Florida, 33782, United States
St. Petersburg Arthritis Center
St. Petersburg, Florida, 33710, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
North Georgia Internal Medicine
Woodstock, Georgia, 30189, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Sonoma Clinical Research, LLC.
Boise, Idaho, 83702, United States
Sonora Clinical Research
Boise, Idaho, 83702, United States
Apex Medical Research, AMR, Inc.
Chicago, Illinois, 60616, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67203, United States
Wichita Clinic PA
Wichita, Kansas, 67208, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504, United States
BenchMark Research
Metairie, Louisiana, 70006, United States
Arthritis Treatment Center
Frederick, Maryland, 21702, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Ann Arbor Clinical Reserch
Ann Arbor, Michigan, 48103, United States
Troy Internal Medicine, PC
Troy, Michigan, 48098, United States
Arthritis Associates, PLLC
Hattiesburg, Mississippi, 39402, United States
Billings Clinic Infusion Center
Billings, Montana, 59101, United States
Billings Clinic Research Center
Billings, Montana, 59101, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Midwest Minor Medical
Omaha, Nebraska, 68114, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
Midwest Minor Medical
Omaha, Nebraska, 68127, United States
Midwest Minor Medical
Omaha, Nebraska, 68144, United States
G. Timothy Kelly, MD
Las Vegas, Nevada, 89128, United States
Andrew Porges, MD, PC
Roslyn, New York, 11576, United States
PMG Research of Charlotte
Charlotte, North Carolina, 28209-3734, United States
Greensboro Imaging
Greensboro, North Carolina, 27407, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina, 27612, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Community Research
Cincinnati, Ohio, 45245, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, 45246, United States
LION Research
Norman, Oklahoma, 73069, United States
McBride Clinic
Norman, Oklahoma, 73072, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Lebanon Internal Medicine Associates
Lebanon, Pennsylvania, 17042, United States
Founders Research Corporation
Philadelphia, Pennsylvania, 19152, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
SoFHA Clinical Research
Johnson City, Tennessee, 37604, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Tekton Research, Inc.
Austin, Texas, 78745, United States
Tekton Research, Inc
Austin, Texas, 78745, United States
Westbury Medical Clinic
Houston, Texas, 77005, United States
Asif Cochinwala, MD, P.A.
Houston, Texas, 77008, United States
Accurate Clinical Research
Houston, Texas, 77034, United States
Mercury Clinical Research
Houston, Texas, 77036, United States
Pioneer Research Solutions, Inc
Houston, Texas, 77036, United States
Clinical Trial Network
Houston, Texas, 77074, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Little York Medical Center
Houston, Texas, 77093, United States
Internist Associates of Texas
Kingwood, Texas, 77339, United States
Accurate Clinical Research Inc
Nassau Bay, Texas, 77058, United States
Clinical Investigations of Texas, LLC
Plano, Texas, 75075, United States
Benchmark Research
San Angelo, Texas, 76904, United States
Pioneer Research Solutions, Inc
Sugar Land, Texas, 77479, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Hypothe Test, LLC
Roanoke, Virginia, 24018, United States
Mountain State Clinical Research
Clarksburg, West Virginia, 26301, 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: 37460782DERIVEDBerenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.
PMID: 34626502DERIVEDBerenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.
PMID: 33973384DERIVEDTive 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: 30936738DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to United States Food and Drug Administration (FDA) imposed clinical hold, enrollment was stopped prematurely and, therefore, was insufficient to yield adequate power to fulfill the primary objectives.
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
March 11, 2010
First Posted
March 18, 2010
Study Start
March 30, 2010
Primary Completion
November 8, 2010
Study Completion
February 18, 2011
Last Updated
May 5, 2021
Results First Posted
May 5, 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.