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- To demonstrate that SAR153191 on top of Methotrexate (MTX) is effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks (Part A)
- To demonstrate that SAR153191 on top of MTX is effective on reduction of signs and symptoms of rheumatoid arthritis at 24 weeks (Part B)
For Part B: to demonstrate that SAR153191 on top of MTX is effective on:
- inhibition of progression of structural damage at 52 weeks
- improvement in physical function at 52 weeks
- induction of a major clinical response at 52 weeks
To assess the safety of SAR153191 on top of MTX.
To document the pharmacokinetic profile of SAR153191 on top of MTX, in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy.
The maximum study duration for a patient is 22 weeks for Part A and 62 weeks for Part B.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Sanofi-Aventis Investigational Site Number 840007
Published on BioPortfolio: 2014-07-24T14:10:07-0400
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