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Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis — JIA  

Juvenile Idiopathic Arthritis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02024334
Study type Interventional
Source Mashhad University of Medical Sciences
Contact Zahra Rezaieyazdi, MD
Phone 009809153115860
Email rezaieyazdiz@mums.ac.ir
Status Recruiting
Phase Phase 4
Start date June 2013
Completion date December 2014
View Details
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