Tanezumab in Osteoarthritis of the Knee
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
2 other identifiers
interventional
697
1 country
82
Brief Summary
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee 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 Sep 2008
Shorter than P25 for phase_3
82 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 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 13, 2008
CompletedStudy Start
First participant enrolled
September 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2010
CompletedResults Posted
Study results publicly available
March 22, 2021
CompletedMarch 22, 2021
February 1, 2021
11 months
August 11, 2008
February 24, 2021
February 24, 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 for pain, stiffness and physical function in participants with osteoarthritis (OA). WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 5 individual questions, each scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (extreme pain), where higher scores indicate higher pain. Total score range for WOMAC pain subscale score is 0 (no pain) to 10 (extreme pain), where higher scores indicate higher 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 for pain, stiffness and physical function in participants with OA. WOMAC physical function is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index knee during past 48 hours. It is calculated as mean of the scores from 17 individual questions, each scored on a NRS of 0 (no difficulty) to 10 (extreme difficulty), where higher scores indicate worse function. Total score range for WOMAC physical function subscale score is 0 (no difficulty) to 10 (extreme 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 (PGA) of Osteoarthritis at Week 16: 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 on a scale ranging from 1-5, where 1= very good (no symptom 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 and inability to carry out all normal activities). Higher scores indicated worsening of condition.
Baseline, Week 16
Secondary Outcomes (25)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 2, 4, 8, 12, 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) Pain Subscale at Week 2, 4, 8, 12, 16, 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 Function Subscale at Week 2, 4, 8, 12, 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 Function Subscale at Week 2, 4, 8, 12, 16, 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) Stiffness Subscales at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward (BOCF)
Baseline, Week 2, 4, 8, 12, 16, 24
- +20 more secondary outcomes
Study Arms (4)
Tanezumab 10 mg
EXPERIMENTALTanezumab 5 mg
EXPERIMENTALTanezumab 2.5 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the knee according to ACR criteria with a 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 knee injections arthroplasty or replace 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 or intent to become pregnant during the study
- 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 (82)
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, 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 Rearch, LLC
DeLand, Florida, 32720, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
Arthritis Associates of South Florida, Clinical Research Center
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
Neurorehabilitation & Diagnostic Services
Miami, Florida, 33126, United States
Pharmax Research Clinic, LLC
Miami, Florida, 33126, United States
South Medical Research Group
Miami, Florida, 33186, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
The Arthritis Center
Palm Harbor, Florida, 34684, United States
University Clinical Research Incorporated
Pembroke Pines, Florida, 33024, United States
Advent Clinical Research Centers
Pinellas Park, Florida, 33781, United States
AVIVOCLIN Clinical Services
Port Orange, Florida, 32127, United States
Dale G. Bramlet, MD, P.L
St. Petersburg, Florida, 33713, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Laureate Clinical Reseach Group
Atlanta, Georgia, 30342, United States
Jefrey D. Lieberman, MD, PC
Decatur, Georgia, 30033, United States
Early Family Practice Center
Fort Valley, Georgia, 31030, 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
Memorial Health System, Inc./ Michiana Arthritis & Osteoporosis Center
South Bend, Indiana, 46601-1071, United States
Memorial Health System, Inc.
South Bend, Indiana, 46601, United States
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, 46383, United States
Arthritis Center of Lexington
Lexington, Kentucky, 40504, United States
Bluegrass Community Research, Inc
Lexington, Kentucky, 40515, United States
David H. Neustadt P.S.C.
Louisville, Kentucky, 40202, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
The Baton Rouge Clinic
Baton Rouge, Louisiana, 70808, United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Office of Peter A. Holt, MD
Baltimore, Maryland, 21239, 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
Arthritis Associates Inc.
Peabody, Massachusetts, 01960-1628, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Ann Arbor Clinical Research
Ann Arbor, Michigan, 48103, United States
KMED Research
Saint Clair Shores, Michigan, 48081, 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
Clinical Research Consortium
Las Vegas, Nevada, 89119, 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
Health Sciences Research Center at Asthma & Allergy Assoc., PC
Elmira, New York, 14901, United States
Health Sciences Research Center at Asthma and Allergy Associates P.C.
Ithaca, New York, 14850, 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
AAIR Research Center
Rochester, New York, 14618, United States
Arthristis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207-1198, United States
Pharmquest
Greensboro, North Carolina, 27408, United States
C.A.R.E. Center
Raleigh, North Carolina, 27609, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, 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, 16635-0909, United States
Health Concepts
Rapid City, South Dakota, 57702, United States
Appalachian Medical Research
Johnson City, Tennessee, 37604-1417, United States
Walter Chase, MD
Austin, Texas, 78705, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Radiant Research
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
Charlottesville Medical Research
Charlottesville, Virginia, 22911, 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: 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: 26554876DERIVED
Related Links
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 11, 2008
First Posted
August 13, 2008
Study Start
September 15, 2008
Primary Completion
August 24, 2009
Study Completion
January 14, 2010
Last Updated
March 22, 2021
Results First Posted
March 22, 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.