Tanezumab in Osteoarthritis of the Knee - Full Text View

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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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

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

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 May 23, 2013