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Tanezumab in Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733902
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : January 7, 2011
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Brief Summary:
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.

Condition or disease Intervention/treatment Phase
Arthritis Osteoarthritis Biological: tanezumab Biological: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 697 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. WOMAC function [ Time Frame: Week 16 ]
  2. WOMAC pain [ Time Frame: Week 16 ]
  3. Patient Global Assessment of Osteoarthritis [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Womac pain, physical function and stiffness at other timepoints [ Time Frame: Weeks 2, 4, 8, 12, 16 and 32 ]
  2. SF-36 [ Time Frame: Weeks 12 and 24 ]
  3. Daily NRS scores [ Time Frame: daily to Week 32 ]
  4. Safety (AEs, laboratory, ECGs, physical exam, vital signs) [ Time Frame: All weeks ]
  5. Time to discontinuation [ Time Frame: All weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733902

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00733902    
Other Study ID Numbers: A4091011
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011
Keywords provided by Pfizer:
monoclonal antibody
nerve growth factor
anti-nerve growth factor
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs