NCT04692363Unknown不适用
Prevention of Rituximab Related Flare by Plasmapheresis in Cryoglobulinemic Vascularitis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- comparison of frequency of occurrence of flare effects
研究概览
简要总结
Initial worsening following initiation of rituximab therapy in patients with cryoglobulinemic vasculitis was described in 3.6% of cases. This worsening is often a serious condition, with high levels of mortality.
The objective of our study is to evaluate the efficacy of preventive plasmapheresis prior to the introduction of rituximab performed in Montpellier France since 2013 by assessing the frequency and severity of this flare effect in these patients compared to those reported in the literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- 未提供
排除标准
- •Patient who reject the study protocol
- •Patient < 18 years old
结局指标
主要结局
comparison of frequency of occurrence of flare effects
时间窗: 1 day
comparison of frequency of occurrence of flare effects between patients who received plasmapheresis prior to rituximab compared to patients who did not.
次要结局
- evaluation of the severity of the flare effect(1 day)
- impact of known risk factors(1 day)
- evaluation of the safety of plasmapheresis in this indication(1 day)
- evaluation of the efficacy of plasmapheresis on biological parameters(1 day)
研究者
研究点 (1)
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