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.
150 mg tranilast tablets, bid, 12 weeks
75 mg tablets, bid, 12 weeks
Placebo tablets, bid, 12 weeks
Capital Federal, Buenos Aires, Argentina
Luján, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina