Clinical trial NCT00985621: Tanezumab In Osteoarthritis Of The Hip Or Knee
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: monoclonal antibody
RN624
PF-04383119
nerve growth factor
OA
pain
arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 614
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Detailed description: This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Eligibility criteria: Inclusion Criteria:

* osteoarthritis of the knee or hip 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 Score at Week 8: ITT Population
timeFrame: Baseline, Week 8
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: Modified Intent-to-Treat (mITT) Population
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: ITT Population
timeFrame: Baseline, Weeks 2, 4, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 12, and 16: mITT Population
timeFrame: Baseline, Weeks 2, 4, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
timeFrame: Baseline, Week 2, 4, 8, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Weeks 2, 4, 8, 12, and 16: mITT Population
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, 12, and 16: ITT Population
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, 12, and 16: mITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: ITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response at Weeks 2, 4, 8, 12, and 16: mITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With At Least (>=) 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Weeks 2, 4, 8, 12 and 16: mITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: ITT Population
timeFrame: Week 8
measure: Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 8: mITT Population
timeFrame: Week 8
measure: Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8, 12 and 16: ITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Participants With Improvement of At Least (>=) 2 Points From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Weeks 2, 4, 8 12 and 16: mITT Population
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: ITT Population
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
measure: Change From Baseline in Average Pain Score in the Index Knee or Index Hip at Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16: mITT Population
timeFrame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Weeks 2, 4, 8, 12, and 16: ITT Population
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 Weeks 2, 4, 8, 12, and 16: mITT Population
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: ITT Population
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: mITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Weeks 2, 4, 8, 12, and 16: mITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: ITT Population
timeFrame: Baseline, Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Weeks 2, 4, 8, 12, and 16: mITT Population
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: ITT Population
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Domain Scores at Week 12: mITT Population
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: ITT Population
timeFrame: Baseline, Week 12
measure: Change From Baseline in 36-Item Short-Form Health Survey Version 2 (SF-36v2) Physical and Mental Component Aggregate Scores at Week 12: mITT Population
timeFrame: Baseline, Week 12
measure: Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: ITT Population
timeFrame: Baseline, Week 12
measure: Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Health State Profile Utility Score at Week 12: mITT Population
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: ITT Population
timeFrame: Baseline, Week 12
measure: Number of Participants With Change From Baseline in Euro Quality of Life-5 Dimension (EQ-5D) - Individual Dimensions at Week 12: mITT Population
timeFrame: Baseline, Week 12
measure: Number of Participants Who Discontinued From Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
measure: Time to Discontinuation From Study Due to Lack of Efficacy
timeFrame: Baseline up to Week 24
measure: Number of Participants With Rescue Medication (RM) Usage
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Number of Days With Rescue Medication (RM) Usage
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Amount of Rescue Medication Used
timeFrame: Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16, and 18
timeFrame: Baseline, Weeks 2, 4, 8, 12, 16, and 18
measure: Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
timeFrame: Baseline, Week 8 and 18
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after last intravenous dose
measure: Number of Participants With Pre-Specified Opioid-Related Adverse Events According to Severity
timeFrame: Baseline up to 112 days after last intravenous dose
measure: Number of Participants With Adverse Event of Abnormal Peripheral Sensation According to Severity
timeFrame: Baseline up to 112 days after last intravenous dose
measure: Tanezumab Plasma Concentration
timeFrame: Predose, 1 hour post-dose on Day 1, Week 8; Week 18
measure: Total Nerve Growth Factor (NGF) Serum Concentration
timeFrame: Predose, 1 hour post-dose on Day 1, Week 8; Predose: Week 18
Other outcomes:
measure: Number of Participants With Intravenous (IV) Doses of Study Medication
timeFrame: Day 1 up to Week 16
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinics, PC
state: Alabama
city: Mobile
country: United States
facility: Horizon Research Group, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Beverly Hills
country: United States
facility: Osteoporosis Medical Center
state: California
city: Buena Park
country: United States
facility: Med Frontier Clinical Research
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Van Nuys
country: United States
facility: Medvin Clinical Research
state: California
city: Stamford
country: United States
facility: Advanced Radiology
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Cutler Bay
country: United States
facility: Homestead Clinical Research Group, P.A.
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Fruitland Park
country: United States
facility: Florida Clinical Research Center, LLC
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: Community Research Foundation, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Pinellas Park
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Dale G. Bramlet, MD
state: Florida
city: Sarasota
country: United States
facility: Sarasota Center For Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Laureate Clinical Research Group
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America Inc.
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Woodstock
country: United States
facility: North Goergia Internal Medicine
state: Georgia
city: Boise
country: United States
facility: Americana Orthopedics
state: Idaho
city: Boise
country: United States
facility: Sonora Clinical Research, LLC.
state: Idaho
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research
state: Kentucky
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research
state: Maryland
city: Brockton
country: United States
facility: Miray Medical Center
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Incorporated
state: Michigan
city: Biloxi
country: United States
facility: The Center for Clinical Trials
state: Mississippi
city: Saint Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research, Inc.
state: Nebraska
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Omaha
country: United States
facility: Midwest Minor Medical
state: Nebraska
city: Henderson
country: United States
facility: Diagnostic Center of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Office of Matthew Barton, MD
state: Nevada
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
city: Roslyn
country: United States
facility: Office of Andrew J. Porges, MD PC
state: New York
city: Boone
country: United States
facility: MediSpect, LLC
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Hilltop Medical Research Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Downingtown
country: United States
facility: Brandywine Clinical Research
state: Pennsylvania
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic, PA
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Johnson City
country: United States
facility: Appalachian Medical Research Inc.
state: Tennessee
city: Carrollton
country: United States
facility: ClinRx Research, LLC
state: Texas
city: Georgetown
country: United States
facility: Tekton Research, Inc
state: Texas
city: Houston
country: United States
facility: One Step Diagnostic (X-Ray Facility)
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Leander
country: United States
facility: Leander Healthcare Center
state: Texas
city: Richardson
country: United States
facility: ClinRx Research
state: Texas
city: San Antonio
country: United States
facility: Oakwell Clinical research, LLC
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Graz
country: Austria
facility: LKH/Universitatsklinikum Graz
city: Senftenberg
country: Austria
facility: Nuhr Zentrum
city: Wien
country: Austria
facility: ClinPharm International GmbH
city: Wien
country: Austria
facility: Synexus ClinPharm GmbH
city: Wien
country: Austria
facility: Rheuma Zentrum Favoriten
city: Aalborg
country: Denmark
facility: CCBR A/S
city: Ballerup
country: Denmark
facility: CCBR A/S
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital Parker Institute
city: Vejle
country: Denmark
facility: CCBR A/S
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Buch GmbH
city: Berlin
country: Germany
facility: Viereck-Apotheke
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum Apotheke
city: Bochum
country: Germany
facility: ClinPharm International GmbH
city: Bochum
country: Germany
facility: Herz Apotheke
city: Bochum
country: Germany
facility: Synexus ClinPharm GmbH
city: Frankfurt am Main
country: Germany
facility: Synexus ClinPharm GmbH / Frankfurt/M
city: Goppingen
country: Germany
facility: Schiller-Apotheke
city: Goppingen
country: Germany
facility: Schmerz und Palliativ-Zentrum Goppingen
city: Hamburg
country: Germany
facility: Falken Apotheke Hoheluft
city: Hamburg
country: Germany
facility: Klinische Forschung Hamburg GmbH
city: Hannover
country: Germany
facility: Klinische Forschung Hannover-Mitte GmbH
city: Hannover
country: Germany
facility: Löwen Apotheke
city: Leipzig
country: Germany
facility: Synexus ClinPharm GmbH
city: Leipzig
country: Germany
facility: Arkana Apotheke OHG
city: Magdeburg
country: Germany
facility: Synexus ClinPharm GmbH Pruefzentrum Magdeburg
city: Magdeburg
country: Germany
facility: Apotheke im MSZ
city: Offenbach am Main
country: Germany
facility: Schwanen Apotheke am Markt
city: Schwerin
country: Germany
facility: Klinische Forschung Schwerin GmbH
city: Schwerin
country: Germany
facility: Sonnenapotheke
city: Bialystok
country: Poland
facility: Nzoz Centrum Medyczne
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla
city: Lublin
country: Poland
facility: NZOZ REUMED Sp.zo.o.
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska
city: Torun
country: Poland
facility: NZOZ "Nasz Lekarz"
city: Warszawa
country: Poland
facility: Centrum Medyczne OSTEOMED NZOZ
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Senora de la Esperanza
state: A Coruña
city: A Coruna
country: Spain
facility: Complejo Hospitalario Universitario de A Coruna
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya (Hospital Civil)
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya (Hospital Civil)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Goteborg
country: Sweden
facility: Me3plus AB
city: Goteborg
country: Sweden
facility: Me3plus AB
city: Goteborg
country: Sweden
facility: Avdelningen for klinisk provning, Sahlgrenska Universitetssjukhuset
city: Malmö
country: Sweden
facility: Center for Clinical Studies
city: Stockholm
country: Sweden
facility: Bragee Medect AB
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: Spierings ELH, Fidelholtz J, Wolfram G, Smith MD, Brown MT, West CR. A phase III placebo- and oxycodone-controlled study of tanezumab in adults with osteoarthritis pain of the hip or knee. Pain. 2013 Sep;154(9):1603-1612. doi: 10.1016/j.pain.2013.04.035. Epub 2013 Apr 22.