Tanezumab in Osteoarthritis of the Hip or 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 HIP OR KNEE
1 other identifier
interventional
849
1 country
95
Brief Summary
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 Jun 2009
Shorter than P25 for phase_3
95 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 13, 2009
CompletedFirst Posted
Study publicly available on registry
March 17, 2009
CompletedStudy Start
First participant enrolled
June 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2010
CompletedResults Posted
Study results publicly available
May 17, 2021
CompletedMay 17, 2021
March 1, 2021
11 months
March 13, 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 for pain, stiffness and physical function in participants with osteoarthritis of index joint (knee or hip). The WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis of index joint (knee or hip) during past 48 hours. It was calculated as the mean of 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 was 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain.
Baseline, 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 osteoarthritis in index joint (knee or hip). Physical function refers to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale is a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty. Total score range for WOMAC physical function subscale score was 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated worse physical function.
Baseline, Week 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
PGA of osteoarthritis was assessed by asking a question from participants: "Considering all the ways your osteoarthritis in your knee or hip affects you, how are you doing today?" Participants responded on a scale ranging from 1=very good (no symptom and 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 worse condition.
Baseline, Week 16
Secondary Outcomes (32)
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Weeks 2, 4, 8, and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Weeks 2, 4, 8, and 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Weeks 2, 4, 8, and 12
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline, Weeks 2, 4, 8, 12, and 16
Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
Baseline, Weeks 2, 4, 8, and 12
- +27 more secondary outcomes
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATOR4
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the hip or 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, neurological or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (95)
Greystone Medical Research, LLC
Birmingham, Alabama, 35242, United States
Saadat Ansari, MD
Huntsville, Alabama, 35801, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Novara Clinical Research
Mesa, Arizona, 85206, United States
Clinical Research Advantage, Inc.
Mesa, Arizona, 85213, United States
Central Phoenix Medical - Clinical Research Advantage
Phoenix, Arizona, 85020, United States
Paradigm Clinical, Inc
Tucson, Arizona, 85705, United States
eStudySite
Chula Vista, California, 91911, United States
Orthopedic Physicians of Colorado, PC
Englewood, California, 80113, United States
University Parks Hematology/Oncology
Englewood, California, 80113, United States
Edinger Medical Group and Research Center
Fountain Valley, California, 92708, United States
Valley Research
Fresno, California, 93720, United States
Lakewood Orthopedic Medical & Surgical Group
Lakewood, California, 90712, United States
High Desert Medical Group Research for Life
Lancaster, California, 93534, United States
Premiere Clinical Research, LLC
Long Beach, California, 90807, United States
Miracle Mile Medical Center
Los Angeles, California, 90036, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
Del Carmen Medical Center
Reseda, California, 91335, United States
Probe Clinical Research, Corp.
Santa Ana, California, 92701, United States
Lawrence P.McAdam, MD, A Medical Corporation
Thousand Oaks, California, 91360, United States
Westlake Medical Center
Westlake Village, California, 91361, United States
Peak Anesthesia and Pain Management
Centennial, Colorado, 80112, United States
Denver Internal Medicine Group
Denver, Colorado, 80209, United States
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209, United States
Colorado Hematology
Englewood, Colorado, 80110, United States
Colorado Orthopedic Consultants, PC
Englewood, Colorado, 80110, United States
American Clinical Research, LLC
Englewood, Colorado, 80113, United States
Norwalk Medical Group
Norwalk, Connecticut, 06851, United States
Rheumatology Consultants of Delaware
Lewes, Delaware, 19958, United States
HeartCare
Bradenton, Florida, 34202, United States
In Vivo Clinical Research, Inc
Doral, Florida, 33166, United States
S & W Clinical Research
Fort Lauderdale, Florida, 33306, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
Kendall South Medical Center, Inc
Miami, Florida, 33175, United States
Sunshine Research Center
Opa-locka, Florida, 33054, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806, United States
HeartCare Research
Sarasota, Florida, 34232, United States
Tampa Medical Group PA
Tampa, Florida, 33614, United States
Masters of Clinical Research, Inc.
Augusta, Georgia, 30909, United States
River Birch Research Alliance, LLC
Blue Ridge, Georgia, 30513, United States
Millennium Pain Center
Bloomington, Illinois, 61701, United States
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714, United States
Pasadena Pharmacy
Lexington, Kentucky, 40503, United States
The Pain Treatment Center of the Bluegrass
Lexington, Kentucky, 40503, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
Bone and Joint Clinic of Baton Rouge
Baton Rouge, Louisiana, 70808, United States
Gulf Coast Research, LLC
Baton Rouge, Louisiana, 70808, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, 02301, United States
Miray Medical Center
Brockton, Massachusetts, 02301, United States
Great Lakes Research Group, Incorporated
Bay City, Michigan, 48706, United States
Planters Clinic
Port Gibson, Mississippi, 39150, United States
St. John's Medical Research Institute, Inc.
Springfield, Missouri, 65807, United States
Medex Healthcare Research, Inc.
St Louis, Missouri, 63117, United States
Diagnositc Center of Medicine
Henderson, Nevada, 89052, United States
Independent Clinical Researchers
Las Vegas, Nevada, 89103, United States
Wolfson Medical Center
Las Vegas, Nevada, 89103, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Medex Healthcare Research, Inc.
New York, New York, 10004, United States
SPRI Bronx LLC
The Bronx, New York, 10454, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
Providence Health Partners - Center for Clinical Research
Dayton, Ohio, 45439, United States
Orthopedic & Sports Medicine Consultants
Middletown, Ohio, 45042, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Physicians' Research, Inc
Zanesville, Ohio, 43701, United States
PrimeCare of Southeastern Ohio, Inc
Zanesville, Ohio, 43701, United States
Cor Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
The Family Healthcare Center, PA
Clinton, South Carolina, 29325, United States
Southern Orthopaedic Sports Medicine
Columbia, South Carolina, 29204, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Low Country Rheumatology, PA
North Charleston, South Carolina, 29406, United States
The Carolina Center for Rheumatology and Arthritis Care, PA
Rock Hill, South Carolina, 29732, United States
Palmetto Clinical Trial Services, LLC
Simpsonville, South Carolina, 29681, United States
South Austin Orthopedics
Austin, Texas, 78745, United States
Tekton Research Inc. - Research Office
Austin, Texas, 78746, United States
Texas Orthopedic Specialists
Grapevine, Texas, 76051, United States
Foundation for Southwest Orthopedic Research
Houston, Texas, 77030, United States
Southwest Orthopedic Group
Houston, Texas, 77030, United States
The Neurology Center
Houston, Texas, 77030, United States
Gill Orthopedic Center
Lubbock, Texas, 79410, United States
Robert R. King, M.D., PA
Lubbock, Texas, 79410, United States
AZ Clinical Research
Sugar Land, Texas, 77478, United States
Spring Clinical Research
Sugar Land, Texas, 77478, United States
Sugar Land Med-Ped, P.A.
Sugar Land, Texas, 77479, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
J. Lewis Research, Incorporated/Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
Commonwealth Orthopedics & Rehabilitation , P.C.
Arlington, Virginia, 22205, United States
IntegraTrials, LLC
Arlington, Virginia, 22205, United States
Virginia Hospital Center
Arlington, Virginia, 22205, United States
HypotheTest, LLC
Roanoke, Virginia, 24018, United States
Empirical Clinical Trials, LLC
Selah, Washington, 98942, United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204-2336, 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
Related Links
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
March 13, 2009
First Posted
March 17, 2009
Study Start
June 9, 2009
Primary Completion
April 27, 2010
Study Completion
August 16, 2010
Last Updated
May 17, 2021
Results First Posted
May 17, 2021
Record last verified: 2021-03
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.