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Tanezumab and Nerve Function in Arthritis Patients
This study is not yet open for participant recruitment.
Verified by Pfizer, March 2009
First Received: March 17, 2009   No Changes Posted
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00863772
  Purpose

Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.


Condition Intervention Phase
Osteoarthritis
Biological: tanezumab
Other: Placebo
Phase III

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from Baseline in the composite measure (5NC [nd] + HRdb [nd]) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intraepidermal nerve fiber density [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • WOMAC subscales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tanezumab levels in the plasma [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Anti-tanezumab antibodies in the serum [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 369
Study Start Date: May 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Tanezumab 5 mg: Experimental Biological: tanezumab
5 mg dose Intravenously every 8 weeks for duration of study
Tanezumab 10 mg: Experimental Biological: tanezumab
10 mg dose Intravenously every 8 weeks for duration of study
Placebo: Placebo Comparator Other: Placebo
Placebo, Intravenously, every 8 weeks for duration of study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI less or equal to 39 kg/m2
  • Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
  • Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
  • Patients must consent in writing to participate in the study.

Exclusion Criteria:

  • Untreated, uncontrolled diseases,
  • Unwilling or unable to discontinue the use of prohibited medications, including other pain medications, during the screening period and during the study,
  • Significant cardiac disease within the past 6 months
  • Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis, stroke) or signs of neuropathy at screening
  • Known bleeding disorder or anticoagulation therapy
  • Planned surgery during the study period
  • History of alcoholism or drug abuse in the past 2 years
  • Unable to use acetaminophen
  • Use of a biologic (including live vaccines, with the exception of Flumist) within the past 3 months
  • Allergic reaction to a biologic or an antibody in the past
  • Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
  • Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
  • Medical condition that may interfere with study endpoints or safety of the subject as determined by the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863772

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A4091026
Study First Received: March 17, 2009
Last Updated: March 17, 2009
ClinicalTrials.gov Identifier: NCT00863772     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009