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

  Show 65 Study Locations
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:
Arthritis
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014