Clinical trial NCT00863304: Tanezumab in Osteoarthritis of the Hip or Knee (2)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth factor OA pain arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-17
Enrollment: 849
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

* pregnancy or intent to become pregnant
* BMI greater than 39
* other severe pain, significant cardiac, neurological or psychiatric disease

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale at Week 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: 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)
timeFrame: Baseline, Weeks 2, 4, 8, and 12
measure: 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)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: 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)
timeFrame: Baseline, Weeks 2, 4, 8, and 12
measure: 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)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, and 12
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in WOMAC Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With at Least 30 Percent and 50 Percent Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With at Least 2 Points Improvement in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline up to Week 16
measure: Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
timeFrame: Baseline up to Week 16
measure: Change From Baseline in Average Daily Pain Score in the Index Hip or Knee at Weeks 2, 4, 8, 12, and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) at Weeks 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 12, and 16
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Weeks 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Weeks 12, and 16
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Percentage of Participants Who Used Rescue Medication
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Duration of Rescue Medication Use
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Amount of Rescue Medication Taken
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline (Day 1) up to Week 24
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Baseline (Day 1) up to Week 24
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
timeFrame: Baseline (Day 1) up to Week 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 6, 8, 12, 16 and 24
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, and 24
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Level
timeFrame: Baseline, Weeks 8, 16, and 24
measure: Number of Participants With Abnormal Physical Examinations Findings
timeFrame: Baseline (Day 1)
measure: Number of Participants With Adverse Events Associated With Vital Sign Measurements
timeFrame: Baseline (Day 1) up to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Greystone Medical Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Saadat Ansari, MD
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc. / Central Arizona Medical Associates, PC
state: Arizona
city: Mesa
country: United States
facility: Novara Clinical Research
state: Arizona
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical - Clinical Research Advantage
state: Arizona
city: Tucson
country: United States
facility: Paradigm Clinical, Inc
state: Arizona
city: Chula Vista
country: United States
facility: eStudySite
state: California
city: Englewood
country: United States
facility: Orthopedic Physicians of Colorado, PC
state: California
city: Englewood
country: United States
facility: University Parks Hematology/Oncology
state: California
city: Fountain Valley
country: United States
facility: Edinger Medical Group and Research Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Lakewood
country: United States
facility: Lakewood Orthopedic Medical & Surgical Group
state: California
city: Lancaster
country: United States
facility: High Desert Medical Group Research for Life
state: California
city: Long Beach
country: United States
facility: Premiere Clinical Research, LLC
state: California
city: Los Angeles
country: United States
facility: Miracle Mile Medical Center
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Reseda
country: United States
facility: Del Carmen Medical Center
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research, Corp.
state: California
city: Thousand Oaks
country: United States
facility: Lawrence P.McAdam, MD, A Medical Corporation
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Center
state: California
city: Centennial
country: United States
facility: Peak Anesthesia and Pain Management
state: Colorado
city: Denver
country: United States
facility: Denver Internal Medicine Group
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc.
state: Colorado
city: Englewood
country: United States
facility: Colorado Hematology
state: Colorado
city: Englewood
country: United States
facility: Colorado Orthopedic Consultants, PC
state: Colorado
city: Englewood
country: United States
facility: American Clinical Research, LLC
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Medical Group
state: Connecticut
city: Lewes
country: United States
facility: Rheumatology Consultants of Delaware
state: Delaware
city: Bradenton
country: United States
facility: HeartCare
state: Florida
city: Doral
country: United States
facility: In Vivo Clinical Research, Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: S & W Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc
state: Florida
city: Opa-locka
country: United States
facility: Sunshine Research Center
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Sarasota
country: United States
facility: HeartCare Research
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group PA
state: Florida
city: Augusta
country: United States
facility: Masters of Clinical Research, Inc.
state: Georgia
city: Blue Ridge
country: United States
facility: River Birch Research Alliance, LLC
state: Georgia
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Lexington
country: United States
facility: Pasadena Pharmacy
state: Kentucky
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Baton Rouge
country: United States
facility: Bone and Joint Clinic of Baton Rouge
state: Louisiana
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Centers
state: Maryland
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Incorporated
state: Michigan
city: Port Gibson
country: United States
facility: Planters Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute, Inc.
state: Missouri
city: Henderson
country: United States
facility: Diagnositc Center of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Independent Clinical Researchers
state: Nevada
city: Las Vegas
country: United States
facility: Wolfson Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Bronx
country: United States
facility: SPRI Bronx LLC
state: New York
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Providence Health Partners - Center for Clinical Research
state: Ohio
city: Middletown
country: United States
facility: Orthopedic & Sports Medicine Consultants
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Zanesville
country: United States
facility: Physicians' Research, Inc
state: Ohio
city: Zanesville
country: United States
facility: PrimeCare of Southeastern Ohio, Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Cor Clinical Research, LLC
state: Oklahoma
city: Clinton
country: United States
facility: The Family Healthcare Center, PA
state: South Carolina
city: Columbia
country: United States
facility: Southern Orthopaedic Sports Medicine
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: North Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Rock Hill
country: United States
facility: The Carolina Center for Rheumatology and Arthritis Care, PA
state: South Carolina
city: Simpsonville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Austin
country: United States
facility: South Austin Orthopedics
state: Texas
city: Austin
country: United States
facility: Tekton Research Inc. - Research Office
state: Texas
city: Grapevine
country: United States
facility: Texas Orthopedic Specialists
state: Texas
city: Houston
country: United States
facility: Foundation for Southwest Orthopedic Research
state: Texas
city: Houston
country: United States
facility: Southwest Orthopedic Group
state: Texas
city: Houston
country: United States
facility: The Neurology Center
state: Texas
city: Lubbock
country: United States
facility: Gill Orthopedic Center
state: Texas
city: Lubbock
country: United States
facility: Robert R. King, M.D., PA
state: Texas
city: Sugar Land
country: United States
facility: AZ Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Spring Clinical Research
state: Texas
city: Sugar Land
country: United States
facility: Sugar Land Med-Ped, P.A.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Incorporated/Foothill Family Clinic South
state: Utah
city: Arlington
country: United States
facility: Commonwealth Orthopedics & Rehabilitation , P.C.
state: Virginia
city: Arlington
country: United States
facility: IntegraTrials, LLC
state: Virginia
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Roanoke
country: United States
facility: HypotheTest, LLC
state: Virginia
city: Selah
country: United States
facility: Empirical Clinical Trials, LLC
state: Washington
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tive 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.
citation: Ekman 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.