The RITAI Cohort. An Observational Study on Serious Adverse Events Occuring After Rituximab Off-label Use for Auto-immune Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Occurrence of a serious adverse events
研究概览
简要总结
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.
详细描述
Every patient treated by rituximab off -label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (France) is eligible for the study, whatever the dose and the number of planned infusions. The enrollment is definitive at the time the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Pharmacovigilance. Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco- immunological studies.
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
- •Age over 18 years
- •rituximab is prescribed off-label for an auto-immune disorder
- •rituximab prescription is validated by an institutional board
- •Patients have given their informed consent to be included in the cohort
排除标准
- •Follow-up for 6 months presumably doubtful
- •Rituximab is prescribed for rheumatoïd arthritis
- •Rituximab is prescribed for lymphoma
- •Pregnant or breath feeding women
研究组 & 干预措施
The RITAI cohort
Every patient treated by rituximab off-label for auto-immune diseases in the public hospitals of the Midi-Pyrénées County (South of France) is eligible for the study, whatever the dose and planned infusions number. The enrolment is definitive when the first rituximab infusion begins. Follow-up visits are planned at months 1, 3, 6, 12 and 18 after the first infusion. At each visit, the investigators will record the adverse events that have occurred since the last visit. Serious or unexpected adverse events will be systematically monitored and declared to the Department of Pharmacology Pharmacovigilance unit and to Health Authorities (AFSSAPS). Imputability will be quoted according to the French method. A biological collection will be constituted to allow pharmaco-immunological studies.
干预措施: Rituximab (MABTHERA® or RITUXAN®). (Drug)
结局指标
主要结局
Occurrence of a serious adverse events
时间窗: Day 14, Week 6, Month 6, Month 12 and Month 18
次要结局
- Type, severity and frequency of all other adverse events occurring in the year following rituximab(Day 14, Week 6, Month 6, Month 12 and Month 18)
- Factors that may influence the occurrence of infectious adverse events(Day 14, Week 6, Month 6, Month 12 and Month 18)