Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate. A randomized, double-blind, placebo-controlled trial.

Background: Disease-modifying antirheumatic drugs may confer greater benefits when combined with the antimetabolite methotrexate.

Objective: To evaluate the efficacy and safety of leflunomide versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis.

Design: 24-week, multicenter, randomized, double-blind, placebo-controlled trial.