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Study Evaluating TMI-005 in Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00095342
First received: November 2, 2004
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: TMI-005
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Enrollment: 390
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00095342     History of Changes
Other Study ID Numbers: 3140A1-200
Study First Received: November 2, 2004
Last Updated: September 8, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013