Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study

Kojima Toshihisa0 个研究点目标入组 53 人开始时间: 2019年3月7日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 53

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Discontinuation of concomitant methotrexate is clinically feasible for maintaining low disease activity, and may be beneficial from the perspective of reducing gastrointestinal symptoms in Japanese RA patients treated with tocilizumab.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 ot applicable（—）
性别: All

入选标准

•1) Patients fulfilled the 1987 ACR classification criteria or the new ACR/EULAR diagnostic criteria for RA
•2) Patients who had a serum C-reactive protein (CRP) level of >=0.6 mg/dL at the time of initiating TCZ therapy
•3) Patients with sustained low disease activity (CDAI <=10) for >=12 weeks while undergoing combination therapy with TCZ plus MTX
•4) Patients had to be receiving MTX orally at a stable dose of >=6 mg/week, and TCZ at a stable dosage regimen irrespective of the route of administration, for >=12 weeks prior to obtaining informed consent. Patients receiving conventional synthetic DMARDs (csDMARDs) other than MTX or glucocorticoids were eligible, but doses had to be stable for >=12 weeks prior to obtaining informed consent

排除标准

•1) Patients with adherence problems
•2) Patients judged as inadequate at the discretion of inevstigators

研究者

发起方

Kojima Toshihisa

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