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

• Status: Terminated
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dainippon Sumitomo Pharma Europe LTd.
• Treatments: Antirheumatic Agents; Rimacalib

Criteria

Inclusion Criteria:

• Male or female patients aged at least 18 years, with RA for a minimum of 6 months

• Has been receiving methotrexate treatment (stable for 8 weeks)

• Has active disease classified as ACR functional class of I, II or III

Exclusion Criteria:

• Has previously discontinued DMARD therapy due to hepatic intolerance

• Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation

• Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening

• Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation

• Has previously failed 2 or more DMARDS