NCT01803321已完成1 期
A Pilot, Multi-center, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Safety, Tolerability and Preliminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Frequency of treatment emergent adverse events (TEAEs)
研究概览
简要总结
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
Dose 1
干预措施: rilonacept (IL-1 Trap) (Drug)
Cohort 1
Experimental
Dose 1
干预措施: Placebo (Other)
Cohort 2
Experimental
Dose 2
干预措施: rilonacept (IL-1 Trap) (Drug)
Cohort 2
Experimental
Dose 2
干预措施: Placebo (Other)
结局指标
主要结局
Frequency of treatment emergent adverse events (TEAEs)
时间窗: Baseline to Week 123
次要结局
未报告次要终点
研究者
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