Clinical trial NCT00994890: A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
Official title: A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND,LONG TERM STUDY OF THE SAFETY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Double-blind safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-14
Enrollment: 679
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.

Detailed description: Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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 based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);

Exclusion Criteria:

* Body mass index (BMI) of \>39 kg/m2;
* Pregnancy or intent to become pregnant
* Planned surgical procedure during the duration of the study
* History of clinically significant cardiovascular, central nervous system or psychiatric disease
* Previous exposure to exogenous NGF or to an anti NGF antibody;
* Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after last dose of study medication (up to 345 days)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline to Week 50
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Week 50
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2
timeFrame: Baseline, Week 2
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 32
timeFrame: Baseline, Week 32
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 40
timeFrame: Baseline, Week 40
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 48
timeFrame: Baseline, Week 48
measure: Number of Participants With Clinically Significant Change From Baseline in Physical Findings
timeFrame: Baseline to Week 50
measure: Number of Participants With Anti-Drug Antibody (ADA) at Day 1
timeFrame: Day 1
measure: Number of Participants With Anti-Drug Antibody (ADA) at Week 8
timeFrame: Week 8
measure: Number of Participants With Anti-Drug Antibody (ADA) at Week 24
timeFrame: Week 24
measure: Number of Participants With Anti-Drug Antibody (ADA) at Week 50
timeFrame: Week 50
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Baseline up to Week 50
measure: Number of Participants With Injection-Site Reactions at Day 1
timeFrame: Day 1
measure: Number of Participants With Injection-Site Reactions at Week 2
timeFrame: Week 2
measure: Number of Participants With Injection-Site Reactions at Week 4
timeFrame: Week 4
measure: Number of Participants With Injection-Site Reactions at Week 8
timeFrame: Week 8
measure: Number of Participants With Injection-Site Reactions at Week 16
timeFrame: Week 16
measure: Number of Participants With Injection-Site Reactions at Week 24
timeFrame: Week 24
measure: Number of Participants With Injection-Site Reactions at Week 32
timeFrame: Week 32
measure: Number of Participants With Injection-Site Reactions at Week 40
timeFrame: Week 40
Secondary outcomes:
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 2, 4, 8,16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Percentage of Participants With Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Response
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Percentage of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Percentage of Participants With Improvement of At Least 2 Points in Patient Global Assessment (PGA) of Osteoarthritis
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Week 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in WOMAC Pain Subscale Item: Pain When Walking on a Flat Surface at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Change From Baseline in WOMAC Pain Subscale Item: Pain When Going Up or Down Stairs at Week 2, 4, 8, 16, 24, 32, 40, 48 and 56
timeFrame: Baseline, Weeks 2, 4, 8, 16, 24, 32, 40, 48, 56
measure: Time to Discontinuation Due to Lack of Efficacy
timeFrame: Baseline up to Week 50
measure: Number of Participants Who Discontinued Due to Lack of Efficacy
timeFrame: Baseline up to Week 50
measure: Percentage of Participants Who Used Concomitant Analgesic Medication
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
measure: Days Per Week of Concomitant Analgesic Medication Usage
timeFrame: Week 2, 4, 8, 16, 24, 32, 40, 48, 56, 64
Other outcomes:
measure: Number of Participants With Subcutaneous Doses of Study Medication
timeFrame: Day 1 up to Week 24
Locations:
city: Mobile
country: United States
facility: Mobile Diagnostic Center
state: Alabama
city: Mobile
country: United States
facility: Seton Medical Management, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Rheumatology Specialists, Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research, Inc
state: Arizona
city: Scottsdale
country: United States
facility: Advanced Arthritis Care and Research
state: Arizona
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc
state: Arizona
city: Fort Smith
country: United States
facility: Ft. Smith Rheumatology, PC
state: Arkansas
city: Little Rock
country: United States
facility: Larry Watkins, MD
state: Arkansas
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: OrthoArkansas, PA
state: Arkansas
city: Little Rock
country: United States
facility: Radiology Consultants
state: Arkansas
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Los Angeles
country: United States
facility: Pacific Arthritis Care Center
state: California
city: Northridge
country: United States
facility: Staywell Research
state: California
city: Northridge
country: United States
facility: University Imaging Centers
state: California
city: San Leandro
country: United States
facility: C Michael Neuwelt, MD
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Boca Raton
country: United States
facility: RASF Clinical Research Center
state: Florida
city: Lauderdale Lake
country: United States
facility: Sunrise Medical Research
state: Florida
city: Melbourne
country: United States
facility: Melbourne Internal Medicine Associates
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associate
state: Florida
city: Melbourne
country: United States
facility: Osler Medical, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: American Family Medical
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Ocala
country: United States
facility: Paddock Park Clinical Research
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research, Inc
state: Florida
city: Plantation
country: United States
facility: Jarred Frydman, DO
state: Florida
city: Plantation
country: United States
facility: Orthopaedic Center of South Flordia
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research
state: Florida
city: South Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: Tampa
country: United States
facility: Tampa Medical Group, P.A.
state: Florida
city: Gainesville
country: United States
facility: Arthritis Center of North Georgia
state: Georgia
city: Chicago
country: United States
facility: Radiant Research, Inc
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Group Rheumatology
state: Illinois
city: Peoria
country: United States
facility: Methodist Research Administration Office
state: Illinois
city: Rockford
country: United States
facility: Rockford Health Physicians
state: Illinois
city: Overland Park
country: United States
facility: Radiant Research, Inc
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Lexington
country: United States
facility: Kentucky Medical Research Center
state: Kentucky
city: Mount Sterling
country: United States
facility: Central Kentucky Research Associates
state: Kentucky
city: Mount Sterling
country: United States
facility: Mt. Sterling Clinic
state: Kentucky
city: Boston
country: United States
facility: Boston Clinical Trails, Inc.
state: Massachusetts
city: Columbia
country: United States
facility: Woodrail Clinic
state: Missouri
city: Columbia
country: United States
facility: University Physicians
state: Missouri
city: Lee's Summit
country: United States
facility: Kansas City Internal Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Saint Louis
country: United States
facility: Advance Clinical Research Inc
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Saint Louis
country: United States
facility: Barbara A. Caciolo
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research, Inc
state: Montana
city: Grand Island
country: United States
facility: Internal Medical Associates of Grand Island, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Radiant Research, Inc
state: Nevada
city: Orchard Park
country: United States
facility: Buffalo Rheumatology
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates
state: New York
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Durham
country: United States
facility: Robert A. Harrell, MD
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Imaging
state: North Carolina
city: Winston-Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Radiant Research, Inc
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Toledo
country: United States
facility: Bone Joint & Spine Surgeons, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: McBride Clinic
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Fleetwood
country: United States
facility: Integrated Medical Group PC/Fleetwood Clinical Research
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Across America @ Oyster Point Family Health Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Arthritis Group
state: Pennsylvania
city: Wexford
country: United States
facility: Allegheny North Arthritis Center
state: Pennsylvania
city: Yardley
country: United States
facility: Jeffry A. Lindenbaum D.O., P.C.
state: Pennsylvania
city: Anderson
country: United States
facility: Anderson Radiology
state: South Carolina
city: Anderson
country: United States
facility: Primary Care Associates
state: South Carolina
city: Anderson
country: United States
facility: Radiant Research, Inc.
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Germantown
country: United States
facility: Sarah Cannon Research Institute, LLC
state: Tennessee
city: Germantown
country: United States
facility: Wolf River Medical Group. LLC
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Carrollton
country: United States
facility: Office of John M. Joseph, M.D.
state: Texas
city: Dallas
country: United States
facility: Arthritis Care and Diagnostic Center
state: Texas
city: Houston
country: United States
facility: Houston Medical Research Associates
state: Texas
city: Houston
country: United States
facility: Nothwest Diagonstic Clinic, PA
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Center of South Texas
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center, LP
state: Texas
city: Tyler
country: United States
facility: Trinity Clinic, Office of Research Administration
state: Texas
city: Tyler
country: United States
facility: Trinity Clinic, Rheumatology
state: Texas
city: Draper
country: United States
facility: Physicians' Research Options, LLC
state: Utah
city: Draper
country: United States
facility: Lone Peak Family Medicine
state: Utah
city: West Valley City
country: United States
facility: Granger Medical Clinic
state: Utah
city: Burke
country: United States
facility: Arthritis and Rheumatic Disease Associates, PC
state: Virginia
city: Richmond
country: United States
facility: Alan E. Schulman, MD
state: Virginia
city: Richmond
country: United States
facility: Steven Maestrello, M.D.
state: Virginia
city: Kirkland
country: United States
facility: Richard Neiman, MD Inc.
state: Washington
city: Olympia
country: United States
facility: South Puget Sound Clinical Research Center
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare
state: Wisconsin
city: Racine
country: United States
facility: Arthritis Clinic
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: