Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Phase 4

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Drug: Leflunomide

• Registration Number: NCT02024334
• Lead Sponsor: Mashhad University of Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-25
• Last Update Submitted: 2013-12-25
• Study First Posted: 2013-12-31
• Last Update Posted: 2013-12-31
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leflunomide	Leflunomide	leflunomide tablet: for patients less than 20 kg: 10 mg every 2 day, for patients 20 - 40 kg: 10 mg daily, for patients more than 40 kg: 20 mg daily.

Primary Outcome Measures

Name	Time	Method
thirty percent changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)	baseline, week 4, week 8, week 12	6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR (Erythrocyte Sedimentation Rate), CHAQ (Childhood Health Assessment Questionnaire) score.

Secondary Outcome Measures

Name	Time	Method
50% and 70% changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)	baseline, week 4, week 8, week 12	6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.