Rheumatoid Arthritis Clinical Trial
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
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).
Status | Completed |
Enrollment | 390 |
Est. completion date | August 2005 |
Est. primary completion date | August 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Wyeth is now a wholly owned subsidiary of Pfizer |
United States, Canada,
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