Reappraisal of Second-line Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete response (CR) proportion
研究概览
简要总结
There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.
详细描述
There is a deficiency in guidelines about the treatment of autoimmune hemolytic anemia in systemic lupus erythematosus (SLE), especially in refractory cases. Mycophenolate mofetil (MMF) showed promising results in those patients but still, the data available are in form of case reports. So, the investigators will investigate the efficiency of MMF against a well-established treatment Rituximab in the treatment of refractory autoimmune hemolytic anemia in SLE patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •diagnosis of erythematosus (SLE) according to The American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) guidelines.
- •secondary autoimmune hemolytic anemia (AIHA) that does not respond properly to corticosteroid or when the patients are intolerant to treatment, or refuse standard treatment.
排除标准
- •Pregnant or breastfeeding women.
- •any contraindication of the used drugs.
- •any known hypersensitivity of the used drugs.
- •congenital hemolytic anemia.
- •chronic renal failure.
研究组 & 干预措施
MMF arm
干预措施: Mycophenolate Mofetil 500mg (Drug)
Rituximab arm
干预措施: Rituximab (Drug)
结局指标
主要结局
complete response (CR) proportion
时间窗: 12 weeks
CR defined as hemoglobin \> 12 g/dL not attributed to transfusion effect and the normalization of hemolytic markers.
rate of Adverse events
时间窗: 12 weeks
rate of occurrence of adverse events of the both drugs
partial response (PR) proportion
时间窗: 12 weeks
PR defined as hemoglobin 10-12 g/dL or at least ≥ 2 g/dL increase from baseline not attributed to transfusion effect and the normalization of hemolytic markers.
次要结局
- Functional Assessment of Chronic Illness(12 weeks)
研究者
Eman Mohammed Ibrahem Kamel
lecturer in internal medicine department of faculty of medicine,Assiut university
Assiut University