Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

Hoffmann-La Roche0 个研究点目标入组 322 人开始时间: 2011年3月最近更新: 2016年11月2日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Hoffmann-La Roche
入组人数: 322
主要终点: Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra

研究概览研究设计入排标准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 observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months .

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult patients, >/= 18 years of age
•Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
•Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months

排除标准

•Participation in a clinical trial in rheumatoid arthritis

结局指标

主要结局

Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra

时间窗: approximately 29 months

次要结局

Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)(approximately 29 months)
Efficacy: Disease activity score (DAS 28)(approximately 29 months)
Co-medications: dosage and treatment schedules(approximately 29 months)
Safety: Incidence of adverse events(approximately 29 months)

研究者

发起方

Hoffmann-La Roche

申办方类型

Industry

责任方

Sponsor

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