Clinical trial NCT00830063: Tanezumab In Osteoarthritis Of The 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 KNEE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Osteoarthritis
Keywords: monoclonal antibody
RN624
PF-04383119
nerve growth factor
anti-nerve growth factor
OA
pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-27
Enrollment: 832
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: 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.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the 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, neurologic or cardiac 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 (Day 1), 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 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 Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: 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)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: 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)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: 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)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Change From Baseline in Patient Global Assessment of Osteoarthritis at Week 2, 4, 8 and 12: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12
measure: Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Baseline Observation Carried Forward (BOCF)
timeFrame: Weeks 2, 4, 8, 12, 16
measure: Percentage of Responders For Outcome Measures in Rheumatology- Osteoarthritis Research Society International (OMERACT-OARSI): Last Observation Carried Forward (LOCF)
timeFrame: Week 2, 4, 8, 12, 16
measure: Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Baseline Observation Carried Forward (BOCF)
timeFrame: Week 2, 4, 8, 12, 16
measure: Percentage of Participants With at Least 30 Percent, and 50 Percent Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale: Last Observation Carried Forward (LOCF)
timeFrame: Week 2, 4, 8, 12, 16
measure: Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Percentage of Participants With Cumulative Reduction From Baseline up to Week 16 in Western Ontario and McMaster Universities 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 Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
timeFrame: Baseline up to Week 16
measure: Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline for the Average Pain Score in the Index Knee at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Walking on a Flat Surface at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score When Going Up or Down Stairs at Week 2, 4, 8, 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16
measure: Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 12, 16
measure: Change From Baseline in Short-Form 36 Health Survey (SF-36) 8 Health Domains, Mental Component Aggregate and Physical Component Aggregate Scores at Week 12 and 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 12, 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: Week 2, 4, 8, 12, 16
measure: Number of Days Participants Used Rescue Medication
timeFrame: Week 2, 4, 8, 12, 16
measure: Amount of Rescue Medication Taken
timeFrame: Week 2, 4, 8, 12, 16
Other outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)
timeFrame: Day 1 (Baseline) up to Week 24
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Day 1 (Baseline) up to Week 24
measure: Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: Day 1 (Baseline) up to Week 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 8, 12, 16 and 24
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Number of Participants With Positive Anti-Drug Antibody (ADA) Level
timeFrame: Baseline, Week 8, 16, 24
measure: Number of Participants With Clinically Significant Changes in Vital Signs Abnormalities
timeFrame: Day 1 (Baseline) up to Week 24
Locations:
city: Anniston
country: United States
facility: Anniston Medical Clinic, PC
state: Alabama
city: Anniston
country: United States
facility: Pinnaccle Research Group, LLC
state: Alabama
city: Mesa
country: United States
facility: Clinical Research Advantage, Inc. / Mesa Family Medical Center, PC
state: Arizona
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - Arizona Arthritis Center
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph's Mercy Clinic
state: Arkansas
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Thousand Oaks
country: United States
facility: Lawrence P McAdam, MD / A Medical Corporation
state: California
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc.
state: Delaware
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Longwood
country: United States
facility: Adult Medicine Specialists
state: Florida
city: Longwood
country: United States
facility: Genesis Research International
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology of Georgia
state: Georgia
city: Decatur
country: United States
facility: Jeffrey D. Lieberman, MD
state: Georgia
city: Marietta
country: United States
facility: Marietta Rheumatology
state: Georgia
city: Woodstock
country: United States
facility: Physician Pain Care
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Internal Medicine
state: Georgia
city: Boise
country: United States
facility: Sonora Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute, LLC
state: Illinois
city: Morton
country: United States
facility: Koch Family Practice
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Louisville
country: United States
facility: David H. Neustadt, PSC
state: Kentucky
city: Baton Rouge
country: United States
facility: Stanocola Medical Center
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Frederick
country: United States
facility: Arthritis and Osteoporosis Center of Maryland
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology, P.C.
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center, Inc
state: Minnesota
city: Edina
country: United States
facility: Medical Advanced Pain Specialists
state: Minnesota
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Consortium
state: Nevada
city: Las Vegas
country: United States
facility: Mirkil Medical
state: Nevada
city: Las Vegas
country: United States
facility: G. Timothy Kelly, MD
state: Nevada
city: Las Vegas
country: United States
facility: Michael Clifford, MD
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Clinical Research & Osteoporosis Center, Incorporated
state: New Mexico
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Roslyn
country: United States
facility: Andrew J. Porges, MD, PC
state: New York
city: Charlotte
country: United States
facility: Carolina Bone and Joint, PA
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Hilltop Physicians Inc / Hightop Medical Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest Rheumatology and Research Group, LLC
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates Incorporated
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: West Reading
country: United States
facility: Clinical Research Center of Reading, LLP
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Johnson City
country: United States
facility: Appalachian Medical Research, Inc
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Austin
country: United States
facility: Capitol Medical Clinic
state: Texas
city: Austin
country: United States
facility: Office of Walter F Chase, MD, PA
state: Texas
city: Dallas
country: United States
facility: North Texas Joint Care, PA
state: Texas
city: Houston
country: United States
facility: Asif Cochinwala, MD, PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions, Inc
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio Northeast
state: Texas
city: San Antonio
country: United States
facility: Diagnostic Research Group
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: South Texas Radiology Group
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research, LLC
state: Utah
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Portsmouth
country: United States
facility: Arthritis and Rheumatic Diseases
state: Virginia
city: Yakima
country: United States
facility: Clinical Trials Northwest
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.