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Study Evaluating TMI-005 in Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00095342
Recruitment Status : Completed
First Posted : November 3, 2004
Last Update Posted : September 10, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: TMI-005 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Parallel, Randomized Study to Evaluate the Efficacy and Safety of 3 Oral Dose Levels of TMI-005 in Subjects With Active Rheumatoid Arthritis on a Background of Methotrexate
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

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U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet American College of Rheumatology (ACR) criteria for RA
  • Have active RA
  • Disease duration of at least 6 months
  • Disease onset at > 16 years of age.

Exclusion Criteria:

  • Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
  • Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
  • Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article

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): NCT00095342


Locations
United States, Indiana
Indianapolis, Indiana, United States, 46250
United States, New York
Syracuse, New York, United States, 13210
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
West Reading, Pennsylvania, United States, 19611
Canada, Quebec
Montreal, Quebec, Canada, H2L 1S6
Ste-Foy, Quebec, Canada, G1W 4R4
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00095342     History of Changes
Other Study ID Numbers: 3140A1-200
First Posted: November 3, 2004    Key Record Dates
Last Update Posted: September 10, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases