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

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis (RA)

• Registration Number: NCT00296257
• Lead Sponsor: Dainippon Sumitomo Pharma Europe LTd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-24
• Study Completion: 2008-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of SMP-114 versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at Week 24.

Secondary Outcome Measures

Name	Time	Method
To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
To compare the efficacy of SMP-114 versus placebo in terms of change in core variables, time to response, Quality of Life, radiological measurements of joint damage, assessment of safety and tolerability, and PK measurements