临床试验/NCT00144625

NCT00144625已完成3 期

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP

Chugai Pharmaceutical0 个研究点目标入组 19 人开始时间: 2005年2月最近更新: 2009年12月23日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Chugai Pharmaceutical
入组人数: 19
主要终点: Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

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

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 every 3M, LOBS

时间窗: every 3 months

Safety:Incidence and severity of adverse events and adverse drug reactions

时间窗: whole period

Pharmacokinetics:The time course of the trough values for the serum MRA concentration

时间窗: whole period

次要结局

Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each variable of the JIA core set, CRP, pain every 3M, LOBS(every 3 months)

研究者

发起方

Chugai Pharmaceutical

申办方类型

Industry

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