Study Evaluating TMI-005 in Active Rheumatoid Arthritis

Last updated: September 8, 2009
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Overall Status: Completed

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00095342
3140A1-200
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 ordiphtheria interleukin-2 fusion protein or other immunosuppressive biologics (exceptfor anakinra)

  • Largely or wholly incapacitated with the subject bedridden or confined to awheelchair, permitting limited or no self-care

  • Pregnant or breastfeeding women or women planning to become pregnant during the studyor within 12 weeks after the last dose of test article

Study Design

Total Participants: 390
Study Start date:
Estimated Completion Date:
August 31, 2005

Connect with a study center

  • Montreal, Quebec H2L 1S6
    Canada

    Site Not Available

  • Ste-Foy, Quebec G1W 4R4
    Canada

    Site Not Available

  • Trois-Rivieres, Quebec G8Z 1Y2
    Canada

    Site Not Available

  • Saskatoon, Saskatchewan S7K 0H6
    Canada

    Site Not Available

  • Indianapolis, Indiana 46250
    United States

    Site Not Available

  • Syracuse, New York 13210
    United States

    Site Not Available

  • Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • West Reading, Pennsylvania 19611
    United States

    Site Not Available

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