Clinical trial NCT00744471: Tanezumab in Osteoarthritis Of The Hip
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis
Osteoarthritis
Osteoarthritis, Hip
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor anti-nerve growth OA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-01
Enrollment: 627
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 3 doses of tanezumab in osteoarthritis of the hip in patients


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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

Exclusion Criteria:

* Pregnancy
* BMI greater than 39
* Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results

Primary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score 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 Score 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) in Pain Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in Pain Subscale Score at Week 2, 4, 8, 12,16 and 24: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale Score at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Subscale at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 24
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Baseline Observation Carried Forward (BOCF)
timeFrame: Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Response: Last Observation Carried Forward (LOCF)
timeFrame: Week 2, 4, 8, 12 ,16, 24
measure: Percentage of Participants With at Least 30 Percent (%), and 50 % Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 12, 16, 24: Baseline Observation Carried Forward
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With at Least 30 Percent (%), and 50% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12 ,16 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12 ,16, 24
measure: Percentage of Participants With at Least 2 Points Improvement From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8, 12, 16, 24: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 16
measure: Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 16: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 16
measure: Change From Baseline in Average Daily Pain Score in the Hip Joint at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12 ,16, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Average Score at Week 2, 4, 8, 12,16 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) Pain Subscale Item (Pain When Walking on Flat Surface) Score at Week 2, 4, 8, 12, 16 and 24 : Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale (Pain When Going up or Down Stairs) Score at Week 2, 4, 8, 12, 16 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Scores at Week 12 and 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 12, 24
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, 24
measure: Duration of Rescue Medication Use
timeFrame: Week 2, 4, 8, 12, 16, 24
measure: Amount of Rescue Medication Taken
timeFrame: Week 2, 4, 8, 12, 16, 24
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 32
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 4, 6, 8, 12, 16 and 24
timeFrame: Baseline, Week 2, 4, 6, 8, 12, 16, 24
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group
state: Alabama
city: Paradise Valley
country: United States
facility: Arizona Arthritis & Rheumatology Associates, PC
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Center
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc. /Stonecreek Medical Associates, PC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, PC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical and Research Center
state: Arizona
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph's Mercy Clinic
state: Arkansas
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Escondido
country: United States
facility: Arthritis Medical Clinic of North County, Inc.
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: Santa Ana
country: United States
facility: Trinity Clinical Trials
state: California
city: Danbury
country: United States
facility: Clinical Research Center of Connecticut
state: Connecticut
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: DeLand
country: United States
facility: Avail Clinical Research, LLC
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
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: International Research Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers
state: Florida
city: Port Orange
country: United States
facility: Avivoclin Clinical Services
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: All Florida Orthopaedic Associates
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: Atlanta
country: United States
facility: Laureate Clinical Reseach Group
state: Georgia
city: Fort Valley
country: United States
facility: Early Family Practice Center
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Diagnostic Clinic
state: Georgia
city: Marietta
country: United States
facility: North Georgia Clinical Research
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: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Fishers
country: United States
facility: American Health Network of IN, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Frederick
country: United States
facility: The Arthritis and Osteoporosis Center of Maryland
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Mansfield
country: United States
facility: Mansfield Health Center
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: Ann Arbor Clinical Research
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology, PC
state: Michigan
city: Edina
country: United States
facility: MAPS Applied Research Center
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: Office of Dr. Danka Michaels, 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: Brooklyn
country: United States
facility: Arthritis and Osteoporosis Center of Brooklyn Heights
state: New York
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Plainview
country: United States
facility: Prem C. Chatpar, MD, LLC
state: New York
city: Roslyn
country: United States
facility: Office of Dr. Andrew Porges
state: New York
city: Charlotte
country: United States
facility: Carolina Bone & Joint, P.A.
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research/Ohio GI and Liver Institute
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,Inc
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Beaverton
country: United States
facility: EPIC Imaging West
state: Oregon
city: Portland
country: United States
facility: EPIC Imaging East
state: Oregon
city: Portland
country: United States
facility: Covance CRU, Inc.
state: Oregon
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
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: Capital Medical Clinic
state: Texas
city: Austin
country: United States
facility: Walter Chase MD
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Houston
country: United States
facility: Pioneet Research Solutions, Inc
state: Texas
city: Plano
country: United States
facility: Clinical Investigations of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio NE
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center, PA
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: Spring
country: United States
facility: Sushma V. Gorrela, MD
state: Texas
city: Salt Lake City
country: United States
facility: Optimum Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Tacoma
country: United States
facility: Internal Medicine Northwest, Frank S Baker Center
state: Washington
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: Hochberg 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.
citation: Brown MT, Murphy FT, Radin DM, Davignon I, Smith MD, West CR. Tanezumab reduces osteoarthritic hip pain: results of a randomized, double-blind, placebo-controlled phase III trial. Arthritis Rheum. 2013 Jul;65(7):1795-803. doi: 10.1002/art.37950.