Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)

A Phase II, Randomized Multi-Center, Double-Blind Study of Tranilast With Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients With Active Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate whether tranilast at two different dosages compared to placebo is effective in patients with active RA when added to continuing methotrexate (MTX) therapy.

The primary objective of this study is to assess the efficacy and safety of two different doses of tranilast as determined by ACR20 response at 12 weeks.

Inclusion Criteria:

• Receiving methotrexate
• Have at least 8 painful/tender and 6 swollen joints
• May be receiving oral steroids, chronic NSAIDs and/or hydroxychloroquine.

Exclusion Criteria:

• Use of any anti-arthritic treatments except those allowed in inclusion criteria
• Pregnant or nursing females
• Abnormal laboratory values
• History of clinically significant renal, hepatic dysfunction, psychiatric disorder, or alcohol/drug dependence
• Clinically significant systemic infection