Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
Status:
Terminated
Trial end date:
2008-04-01
Target enrollment:
Participant gender:
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.