Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •JIA based on ACR criteria
- •age between 2- 19 y
- •polyarticular, oligoarticular(> or = 3 active joints) or extended oligoarticular subtypes
- •resistance to conventional treatment
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Leflunomide (Drug)
结局指标
主要结局
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)
时间窗: 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.
次要结局
- 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)
研究者
Zahra Rezaieyazdi
Mashhad University of Medical Sciences
Mashhad University of Medical Sciences