NCT00144599已完成3 期
A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
研究概览
简要总结
This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2
Placebo Comparator
干预措施: placebo (Drug)
1
Experimental
干预措施: MRA(Tocilizumab) (Drug)
结局指标
主要结局
Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
时间窗: open-label period
Efficacy:Percentage of patients in whom effects were maintained
时间窗: Blind period
Safety:Incidence and severity of adverse events and adverse drug reactions
时间窗: whole period
Pharmacokinetics:The time course of the trough serum MRA concentration
时间窗: whole period
次要结局
- Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score(Open-label period)
- Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS(Blind Period)
研究者
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