Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis

A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis.

Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.

30 Patients(2-19 y) are randomly divided into two groups. In group 1 leflunomide will be added to conventional treatment, 5-20 mg daily based on weight.

In group 2 placebo will be prescribed as same as leflunomide. The course of treatment is 3 months. Every 4 weeks ACRped 30, 50, 70 should be determined to evaluate therapeutic response. Side effects of treatment will be assessed by physical examination and lab tests every 4 weeks.

Inclusion Criteria:

• JIA based on ACR criteria
• age between 2- 19 y
• polyarticular, oligoarticular(> or = 3 active joints) or extended oligoarticular subtypes
• resistance to conventional treatment

Exclusion Criteria:

• pregnancy
• malignancy
• severe active infection
• other rheumatic diseases or overlap
• ALT(Alanine transaminase) or bilirubin > 3 folds
• IVIG (Intravenous immunoglobulin) treatment during last 2 weeks
• biologic agents during last 3 months