Status:
TERMINATED
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
Lead Sponsor:
Dainippon Sumitomo Pharma Europe LTd.
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00296257
Start Date
February 1 2006
End Date
April 1 2008
Last Update
March 13 2009
Active Locations (46)
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1
Česká Lípa, Czechia, 470 01
2
České Budějovice, Czechia, 370 00
3
Hlučín, Czechia, 748 01
4
Ostrava Trebovice, Czechia, 722 00