NCT02024334

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mashhad University of Medical Sciences · Academic / Other
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Leflunomide

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-12-01
• First posted: 2013-12-31
• Last updated: 2013-12-31

Locations

1 site across 1 country: Iran