A Phase 4 interventional study of Leflunomide in Juvenile Idiopathic Arthritis, sponsored by Mashhad University of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to participants aged 2 Years to 19 Years. Per ClinicalTrials.gov, last updated 2013-12-31.
Sponsored by Mashhad University of Medical Sciences · Phase 4, Interventional, and Treatment
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Mashhad University of Medical Sciences is the lead sponsor of 90 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Also known as: arava
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.
Time frame: baseline, week 4, week 8, week 12
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.
Time frame: baseline, week 4, week 8, week 12
This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Mashhad University of Medical Sciences