Study Evaluating TMI-005 in Active Rheumatoid Arthritis

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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).

Key facts

Study ID

NCT00095342

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

390

Expected to finish

2005-08-01

Last updated by the study team

2009-09-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Indianapolis, Indiana, United States
• Study site — Syracuse, New York, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Montreal, Quebec, Canada
• Study site — Ste-Foy, Quebec, Canada
• Study site — Trois-Rivières, Quebec, Canada
• Study site — Saskatoon, Saskatchewan, Canada

Full record on ClinicalTrials.gov

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