Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
研究概览
简要总结
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune diseases.
The major drawback of this drug is the risk of infection, which are favored by the direct effect of rituximab on the immune system. The risk of infection is one of the major reason not to prescribe or withdraw rituximab in several patients. However, many questions remain unanswered regarding the proportion and risk factors of infection or immunodeficiency induced by rituximab. Better understanding of these issues will help prescribing rituximab and properly monitor patients during their treatment. Moreover, as treatment with substitutive immunoglobulins might be a solution to decrease the risk of infections in those patients, it is very important to better characterize the risk and risk factors of rituximab-associated infection. The present study aims to answer these questions.
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
- •Patient initiating treatment with RTX, delivered by the central pharmacy of Lille University Hospital
- •Inpatient or outpatient at Lille University Hospital (in one of the following departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and monitored every three months as part of routine care (as part of the surveillance of induction of RTX treatment)
- •Patient with one of the following autoimmune diseases, defined by international criteria
排除标准
- •Treatment with rituximab for a malignancy or a transplant reject
- •Pregnant or lactating women
- •People in emergency
- •Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system, refusal to sign consent
- •Persons deprived of their liberty
- •People unable to consent
结局指标
主要结局
Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
时间窗: Within 12 months after inclusion
A serious infection event \[SIE\] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs
次要结局
- Hypogammaglobulinemia(Within 12 months after inclusion)
- Replacement therapy with immunoglobulins(Within 12 months after inclusion)
- Hypersensitivity skin reaction secondary to RTX injection.(Within 12 months after inclusion)