A 24-week, Double-blind, Randomized, Placebo-controlled, Multicenter Study, to Evaluate the Effectiveness of Cyclosporine 2,5 mg/kg/Day Bid Twice a Week on Reducing Relapse Rate, in Maintenance Patients With Chronic Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score
研究概览
简要总结
The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cyclosporine A
Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations
干预措施: Cyclosporine A microemulsion (Drug)
Placebo
Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Relapse Rate (Success or Failure), as Assessed by Psoriasis Area and Severity Index (PASI) Score
时间窗: 24 weeks
PASI is an index used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI produces a numeric score that can range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of severest degree. Relapse is considered a worsening of psoriasis associated to a PASI score \>75% of PASI score recorded before starting induction therapy with CsA (before study start). Each patient was considered as failure (relapse occurrence) if rate was \>= 75%. In all the other cases the patient was considered as success (no relapse).
次要结局
- Proportion of Participants With Clinical Relapse(24 weeks)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) Score(baseline and week 24)
- Change From Baseline in Body Surface Area (BSA) Affected by Psoriasis(Baseline and week 24)
- Change From Baseline in Visual Analogue Scale (VAS) for Patient Self Assessment of Pruritus(Baseline and week 24)
- Safety / Tolerability Assessed by Adverse Events(24weeks)