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Tanezumab and Nerve Function In Arthritis Patients

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.
 
ClinicalTrials.gov Identifier: NCT00863772
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : March 18, 2009
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

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

Detailed Description:
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 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 Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Tanezumab 5 mg Biological: tanezumab
5 mg dose Intravenously every 8 weeks for duration of study

Experimental: Tanezumab 10 mg Biological: tanezumab
10 mg dose Intravenously every 8 weeks for duration of study

Placebo Comparator: Placebo Other: Placebo
Placebo, Intravenously, every 8 weeks for duration of study




Primary Outcome Measures :
  1. Change from Baseline in the composite measure (5NC [nd] + HRdb [nd]) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Intraepidermal nerve fiber density [ Time Frame: 6 months ]
  2. WOMAC subscales [ Time Frame: 6 months ]
  3. Patient's Global Assessment of Arthritis [ Time Frame: 6 months ]
  4. Tanezumab levels in the plasma [ Time Frame: 6 months ]
  5. Anti-tanezumab antibodies in the serum [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00863772


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00863772    
Other Study ID Numbers: A4091026
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs