Combination leflunomide and methotrexate (MTX) therapy for patients with active rheumatoid arthritis failing MTX monotherapy: open-label extension of a randomized, double-blind, placebo controlled trial.

Objective: To obtain additional safety and efficacy data on leflunomide (LEF) treatment in combination with methotrexate (MTX) therapy in an open-label extension study in patients with rheumatoid arthritis (RA).

Methods: Following a 24 week, randomized, double-blind trial of adding placebo (PLA) or LEF to stable MTX therapy, patients could enter a 24 week extension. Subjects randomized to LEF and MTX continued treatment [(LEF/LEF) + MTX].

Height loss and osteoporosis of the hip.

Osteoporosis of the hip is associated with hip fracture, a devastating outcome on both an individual and aggregate basis. Height loss is a frequent manifestation of vertebral osteoporosis and is simple to evaluate in the clinical setting. The goal of this study was to determine whether height loss is significantly associated with low bone mineral density at the femur, using a retrospective review of cross-sectional data from 2108 women referred for a bone density scan.

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.