临床试验/NCT02721004

NCT02721004已完成不适用

Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis

Hoffmann-La Roche0 个研究点目标入组 592 人开始时间: 2009年3月最近更新: 2016年7月4日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 592
主要终点: Simplified Disease Activity Index (SDAI) Score

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, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Cross Sectional

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Participants with rheumatoid arthritis receiving tocilizumab as per product label

排除标准

•No specific exclusion criteria were specified for this non-interventional trial

研究组 & 干预措施

Rheumatoid arthritis participants

Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

干预措施: Tocilizumab (Drug)

结局指标

主要结局

Simplified Disease Activity Index (SDAI) Score

时间窗: Month 12

Clinical Disease Activity Index (CDAI) Score

时间窗: Month 12

Percentage of Participants Achieving American College of Rheumatology (ACR) Response

时间窗: Month 12

Swollen Joint Count (SJC)

时间窗: Month 12

Tender Joint Count (TJC)

时间窗: Month 12

Disease Activity Score Based on 28-joints Count (DAS28)

时间窗: Month 12

次要结局

Percentage of Participants with any Adverse Event (AE)(Up to 36 months)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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