NCT02322801已完成不适用
Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 主要终点
- Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment
研究概览
简要总结
This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts
排除标准
- •Patients with serious infections
结局指标
主要结局
Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment
时间窗: Up to 31 months (24 months each patient)
次要结局
- Percent of patients with at least one severe adverse event (SAE)(Up to 31 months (24 months each patient))
- Percent of patients who discontinued therapy with RTX(Up to 31 months (24 months each patient))
- Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs(Up to 31 months (24 months each patient))
- Time to response and duration of response to RTX(Up to 31 months (24 months each patient))
- Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline(Up to 31 months (24 months each patient))
- Time to "re-treatment" with RTX(Up to 31 months (24 months each patient))
研究者
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