Overview

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Status:
Unknown status
Trial end date:
2014-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mashhad University of Medical Sciences
Treatments:
Leflunomide
Criteria
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