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临床试验/NCT00656656
NCT00656656已完成2 期

Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab

University of Luebeck1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

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

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

Other

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

发起方
University of Luebeck
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Kasperkiewicz

Dermatologist

University of Luebeck

研究点 (1)

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