Open, Multicenter, Randomized Clinical Trial in Patients With Moderate-Severe Psoriasis (PASI > 10) to Compare the Efficacy of Mycophenolate Mofetil Versus Cyclosporine A.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Comparison of the two treatment arms with regard to time until psoriasis recurrence.
研究概览
简要总结
Psoriasis is an immuno-mediated skin disorder, which affects about 2-3% of the population worldwide. For moderate-severe forms of psoriasis systemic immunosuppression is the treatment of choice. This clinical trial was initiated to compare the safety and effectiveness of mycophenolate mofetil and cyclosporine A for the treatment of psoriasis. Patients are randomized to receive either 2.5 mg/kg BW cyclosporine A or 1 g bid mycophenolate mofetil. If after six weeks no decrease in the PASI score occures cyclosporine A doses are increased to 5 mg/kg BW for additional six weeks. In the other arm mycophenolate mofetil is increased to 1 g tid for additional six weeks.
详细描述
Not needed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-to-severe psoriasis (PASI Score equal and greated 10)
- •written informed consent
- •for female patients effective birth control
排除标准
- •psoriasis arthritis
- •psoriasis palmo-plantaris
- •erythrodermic psoriasis
- •drug-induced psoriasis
- •pregnancy
- •previous treatment with cyclosporine A or mycophenolate mofetil
- •pregnancy
- •reduced liver function
- •high blood pressure
- •reduced kidney function
- •severe viral or bacterial infection
- •2 weeks before or after vaccinations
- •innate or acquired immunodeficiency
- •severe neurologic or psychiatric symptoms
- •participation in other trials
- •other reasons voiced by the treating physician
结局指标
主要结局
Comparison of the two treatment arms with regard to time until psoriasis recurrence.
次要结局
- The treatment that leads to a 75% decrease of the initial PASI score.
- The time until complete remission.
- The time until partial remission has occured.
- The rate of complete remission.
- The rate of partial remission.
- The cumulative cyclosporine A or mycophenolate mofetil doses.