Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
研究概览
简要总结
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 pemphigus confirmed by immunofluorescence and desmoglein ELISA.
- •Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.
排除标准
- •General condition too poor to tolerate immunoadsorption treatment.
- •Severe dementia or psychiatric disease.
研究组 & 干预措施
Immunoadsorption/Dexamethasone/Rituximab
干预措施: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine (Drug)
结局指标
主要结局
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
时间窗: up to 43 months
Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
次要结局
- Number of Patients Who Experienced Side-effects of Treatment(up to 43 months)
研究者
Michael Kasperkiewicz
Dermatologist
University of Luebeck
