Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: Leflunomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: leflunomide<br>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. | Drug: Leflunomide<br> <br> * Other names: arava;|
| Placebo Comparator: placebo<br>placebo 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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | baseline, week 4, week 8, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score. | baseline, week 4, week 8, week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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JIA, LEFLUNOMIDE, EFFICACY