Tanezumab in Osteoarthritis of the Knee

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00733902
First received: August 11, 2008
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.


Condition Intervention Phase
Arthritis
Osteoarthritis
Biological: tanezumab
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • WOMAC function [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • WOMAC pain [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Daily NRS scores [ Time Frame: daily to Week 32 ] [ Designated as safety issue: No ]
  • Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ] [ Designated as safety issue: Yes ]
  • Time to discontinuation [ Time Frame: All weeks ] [ Designated as safety issue: No ]

Enrollment: 697
Study Start Date: September 2008
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 10 mg Biological: tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
Experimental: Tanezumab 5 mg Biological: tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
Experimental: Tanezumab 2.5 mg Biological: tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
Placebo Comparator: Placebo Biological: Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733902

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810
Pfizer Investigational Site
Stamford, Connecticut, United States, 06905
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33761
Pfizer Investigational Site
DeLand, Florida, United States, 32720
Pfizer Investigational Site
Delray Beach, Florida, United States, 33484
Pfizer Investigational Site
Jacksonville, Florida, United States, 32205
Pfizer Investigational Site
Largo, Florida, United States, 33770
Pfizer Investigational Site
Miami, Florida, United States, 33186
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Orlando, Florida, United States, 32806
Pfizer Investigational Site
Palm Harbor, Florida, United States, 34684
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33024
Pfizer Investigational Site
Pinellas Park, Florida, United States, 33781
Pfizer Investigational Site
Port Orange, Florida, United States, 32127
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33409
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Fort Valley, Georgia, United States, 31030
Pfizer Investigational Site
Woodstock, Georgia, United States, 30189
United States, Idaho
Pfizer Investigational Site
Boise, Idaho, United States, 83702
United States, Illinois
Pfizer Investigational Site
Springfield, Illinois, United States, 62704
United States, Indiana
Pfizer Investigational Site
South Bend, Indiana, United States, 46601-1071
Pfizer Investigational Site
Valparaiso, Indiana, United States, 46383
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
Pfizer Investigational Site
Loiusville, Kentucky, United States, 40202
United States, Louisiana
Pfizer Investigational Site
Baton Rouge, Louisiana, United States, 70808
Pfizer Investigational Site
Monroe, Louisiana, United States, 71203
United States, Maine
Pfizer Investigational Site
Auburn, Maine, United States, 04210
United States, Maryland
Pfizer Investigational Site
Frederick, Maryland, United States, 21702
Pfizer Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Pfizer Investigational Site
Mansfield, Massachusetts, United States, 02048
Pfizer Investigational Site
Peabody, Massachusetts, United States, 01960-1628
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48103
Pfizer Investigational Site
St. Clair Shores, Michigan, United States, 48081
United States, Minnesota
Pfizer Investigational Site
Edina, Minnesota, United States, 55435
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nevada
Pfizer Investigational Site
Las Vegas,, Nevada, United States, 89119
United States, New Jersey
Pfizer Investigational Site
Berlin, New Jersey, United States, 08009
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87106
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10024
Pfizer Investigational Site
Plainview, New York, United States, 11803
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28207-1198
Pfizer Investigational Site
Greensboro, North Carolina, United States, 27408
Pfizer Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45224
Pfizer Investigational Site
Middleburg Heights, Ohio, United States, 44130
Pfizer Investigational Site
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States, 73109
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Pfizer Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Pfizer Investigational Site
Downingtown, Pennsylvania, United States, 19335-2620
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635-0909
United States, South Dakota
Pfizer Investigational Site
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Pfizer Investigational Site
Johnson City, Tennessee, United States, 37604-1417
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Pfizer Investigational Site
Dallas, Texas, United States, 75235
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Pfizer Investigational Site
San Antonio, Texas, United States, 78217
United States, Virginia
Pfizer Investigational Site
Charlottesville, Virginia, United States, 22911
United States, Washington
Pfizer Investigational Site
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00733902     History of Changes
Other Study ID Numbers: A4091011
Study First Received: August 11, 2008
Last Updated: January 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
monoclonal antibody
RN624
PF-04383119
nerve growth factor
anti-nerve growth factor
OA
pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014