Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 主要终点
- The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.
研究概览
简要总结
The aim of this large French multicentric retrospective study was to compare the efficacy and safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's immune thrombocytopenia .
详细描述
Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille, Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according to the American Society Hematology guidelines who received RTX regardless the regimen could be included.
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
- •Primary ITP
- •Age > 18 years
排除标准
- •Secondary ITP
- •Age < 18 years
结局指标
主要结局
The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.
时间窗: one year
A complete response (CR) was defined as a platelet count \>100 x 109/l and a response (R): by a platelet count \>30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/
次要结局
- The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.(3 months, one year, last follow-up)
研究者
Dr Mahévas Matthieu, MD
MD
Henri Mondor University Hospital