The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- remission or low disease activity
研究概览
简要总结
Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA
详细描述
First group will receive 2 consecutive days intravenous pulse of 125 mg methylprednisolone.
Second group will not receive additional drugs. Assessment was done at baseline and every month for 3 months for both groups using Juvenile Arthritis Disease Activity Score (JADAS) and the American College of Rheumatology Pediatric 30, 50, and 70 response criteria (ACR Pedi. 30, 50, 70).
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
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients still active despite administration o 2 DMARDs
排除标准
- •Other connective tissue diseases
- •Endocrine disorders such as Thyroid disorders.
研究组 & 干预措施
pulse steroid
108 patients will receive 125 mg solumedrol intravenous pulse for 2 consecutive days plus their concomitant medication.
干预措施: Solumedrol (Drug)
without pulse
107 patients will not receive any additional medications.
干预措施: Solumedrol (Drug)
结局指标
主要结局
remission or low disease activity
时间窗: 3 months
patients will be assessed at baseline and every month for 3 months using Juvenile Arthritis Disease Activity Score (JADAS) for disease activity American College of Rheumatology Pediatric 30, 50, and 70 (ACR Pedi. 30, 50, 70) for disease activity
次要结局
未报告次要终点