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

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