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

Sumitomo Pharma

Status and phase

Terminated

Phase 2

Conditions

Rheumatoid Arthritis (RA)

Treatments

Drug: SMP-114

Study type

Interventional

Funder types

Industry

Identifiers

NCT00296257

D2450174

Details and patient eligibility

About

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.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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