Status:
COMPLETED
Study Evaluating TMI-005 in Active Rheumatoid Arthritis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00095342
End Date
August 1 2005
Last Update
September 10 2009
Active Locations (8)
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1
Indianapolis, Indiana, United States, 46250
2
Syracuse, New York, United States, 13210
3
Duncansville, Pennsylvania, United States, 16635
4
West Reading, Pennsylvania, United States, 19611