临床试验/NCT00144547

NCT00144547已完成3 期

An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP

Chugai Pharmaceutical0 个研究点目标入组 241 人开始时间: 2004年4月最近更新: 2013年8月9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: 241
主要终点: Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

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 and efficacy of MRA in patients with RA who participated in Study MRA012JP.

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: 20 Years 至 —（Adult, Older 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

Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

时间窗: 0W,4W,8W,12W,LOBS

Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

时间窗: 0W,4W,8W,12W,LOBS

次要结局

Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set(0W,4W,8W,12W,LOBS)
Frequency, severity, and seriousness of adverse events and adverse drug reactions(Throughout study)

研究者

发起方

Chugai Pharmaceutical

申办方类型

Industry

责任方

Sponsor

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