Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

Summary

To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.

Timeline

Start

2006-02

Primary completion

—

Completion

2008-04

Drugs

Indications