Juvenile Idiopathic Arthritis
Conditions
Keywords
JIA, LEFLUNOMIDE, EFFICACY
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.
Interventions
DRUGLeflunomide
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Iran
Contacts
Primary ContactZahra Rezaieyazdi, MD
Outcome results
None listed