Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis (JIA)
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|ClinicalTrials.gov Identifier: NCT02024334|
Recruitment Status : Unknown
Verified December 2013 by Zahra Rezaieyazdi, Mashhad University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Idiopathic Arthritis||Drug: Leflunomide||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||December 2014|
Active Comparator: 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.
Other Name: arava
Placebo Comparator: placebo
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.
- 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) [ Time Frame: 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.
- 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) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024334
|Contact: Zahra Rezaieyazdi, MDfirstname.lastname@example.org|
|Iran, Islamic Republic of|
|Mashhad, Khorasan Razavi, Iran, Islamic Republic of|
|Contact: Zahra Rezaeiyazdi, MD 00989153115860|
|Sub-Investigator: malihe bokaiyan, MD|
|Principal Investigator:||Zahra Rezaieyazdi, MD||Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran|