The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis in Real-World Clinical Setting
试验速览
- 阶段
- 不适用
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Safety endpoints change from baseline to week 52
研究概览
简要总结
The aim of this study is to investigate the safety and effectiveness of tocilizumab (Actemra®) using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.
详细描述
Tocilizumab (Actemra®) is a humanized monoclonal antibody targeting the human IL-6 receptor, which inhibits the binding of this cytokine to its receptor. It is the first monoclonal antibody developed for RA treatment with this mechanism of action and has been approved by regulatory authorities in China since 2013. Data from five phase III studies with over 4000 recruited patients have shown that tocilizumab at a dose of 8 mg/kg, in combination with methotrexate/DMARDs or as monotherapy, can produce a quick and clinically relevant improvement in RA signs and symptoms, health status, and prevent joint damage, for both patients who have not been previously treated with and refractory to methotrexate, other DMARDs or anti-TNF agents. However, in real-world clinical setting, the safety profile and treatment pattern with regard to the persistence on tocilizumab and the efficacy are not clear in China. The aim of this study is to investigate the safety and effectiveness of tocilizumab using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age.
- •Patients with a diagnosis of RA according to the revised (2010) ACR criteria.
- •Patients per treating physician's judgment to treat with Tocilizumab.
- •Signed written informed consent
排除标准
- •Patients are receiving or have received any investigational agent 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to enrollment of this study.
- •Subjects with contra-indications to Tocilizumab therapy as detailed in the label (with known hypersensitivity to Tocilizumab or accessories; or with active infections.).
结局指标
主要结局
Safety endpoints change from baseline to week 52
时间窗: Baseline, Week 52
Incidence and severity of unexpected AE/ adverse drug reaction（ADR）in RA patients
次要结局
- Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.(Baseline, Week 52)
- Mean changes from baseline in Health Assessment Questionnaire Disability Index score(Baseline, Week 52)