Clinical trial NCT00733902: Tanezumab in Osteoarthritis of the Knee
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 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: 2008-08-13
Enrollment: 697
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: Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

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 (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 Week 2, 4, 8, 12, 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) Pain Subscale at Week 2, 4, 8, 12, 16, 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 Function Subscale at Week 2, 4, 8, 12, 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 Function Subscale at Week 2, 4, 8, 12, 16, 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) Stiffness Subscales at Week 2, 4, 8, 12, 16, 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 at Week 2, 4, 8, 12, 16, 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, 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, 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% and 50% Reduction From Baseline in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale Score: Baseline Observation Carried Forward (BOCF)
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 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: 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: Last Observation Carried Forward (LOCF)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 24
measure: Percentage of Participants With Cumulative Reduction From Baseline 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 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 Pain Score in the Index Knee at Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24: Baseline Observation Carried Forward (BOCF)
timeFrame: Baseline, Week 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 12, 16, 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 at Week 2, 4, 8, 12, 16, 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, 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, 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 Medications
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
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
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 Rearch, 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, Clinical Research Center
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: Miami
country: United States
facility: Neurorehabilitation & Diagnostic Services
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic, LLC
state: Florida
city: Miami
country: United States
facility: South Medical Research Group
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: Pembroke Pines
country: United States
facility: University Clinical Research Incorporated
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: Saint Petersburg
country: United States
facility: Dale G. Bramlet, MD, P.L
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Laureate Clinical Reseach Group
state: Georgia
city: Decatur
country: United States
facility: Jefrey D. Lieberman, MD, PC
state: Georgia
city: Fort Valley
country: United States
facility: Early Family Practice Center
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: South Bend
country: United States
facility: Memorial Health System, Inc./ Michiana Arthritis & Osteoporosis Center
state: Indiana
city: South Bend
country: United States
facility: Memorial Health System, Inc.
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Lexington
country: United States
facility: Arthritis Center of Lexington
state: Kentucky
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc
state: Kentucky
city: Louisville
country: United States
facility: David H. Neustadt P.S.C.
state: Kentucky
city: Baton Rouge
country: United States
facility: Gulf Coast Research, LLC
state: Louisiana
city: Baton Rouge
country: United States
facility: The Baton Rouge Clinic
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic
state: Louisiana
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Baltimore
country: United States
facility: Office of Peter A. Holt, MD
state: Maryland
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: Peabody
country: United States
facility: Arthritis Associates Inc.
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: Saint Clair Shores
country: United States
facility: KMED Research
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: Las Vegas
country: United States
facility: Clinical Research Consortium
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: Elmira
country: United States
facility: Health Sciences Research Center at Asthma & Allergy Assoc., PC
state: New York
city: Ithaca
country: United States
facility: Health Sciences Research Center at Asthma and Allergy Associates P.C.
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: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Charlotte
country: United States
facility: Arthristis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Raleigh
country: United States
facility: C.A.R.E. Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Associates
state: North Carolina
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
state: Tennessee
city: Austin
country: United States
facility: Walter Chase, MD
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Radiant Research
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: Charlottesville
country: United States
facility: Charlottesville Medical Research
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: 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.