Status:
COMPLETED
SPRiNG: SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
Lead Sponsor:
Scios, Inc.
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging (hepatotoxic) disease-modifying anti-rheuma...
Detailed Description
This is a 24 week randomized (study drug assigned by chance), double blind (neither physician nor patient knows the name of the assigned drug), placebo controlled, parallel group study assessing the s...
Eligibility Criteria
Inclusion
- Patients having active rheumatoid arthritis who are not receiving medications known as hepatotoxic disease-modifying anti-rheumatic drugs (DMARDs)
- Patients taking hydroxychloroquine (Plaquenil) must be on a stable or consistent dose prior to entering study
Exclusion
- Patients using Enbrel, Remicade, Kineret, Humira, or an experimental biologic agent within the past 3 months
- Lab tests revealed elevated liver enzymes within the past 6 months
- Medical history of Tuberculosis, cancer, multiple sclerosis, neuropathy or encephalopathy
- HIV positive
- Abnormal electrocardiogram
- Chronic or acute infection
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT00089921
Start Date
July 1 2004
End Date
October 1 2005
Last Update
October 18 2010
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