Study Evaluating TMI-005 in Active Rheumatoid Arthritis
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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).
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 :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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