NCT00422617已完成不适用
Evaluate the Efficacy and Safety of One Course of Amevive in Taiwan Patients
Uni-Pharma0 个研究点目标入组 40 人开始时间: 2005年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
研究概览
简要总结
An open-label, multicentre study to evaluate the efficacy and safety of one course of weekly intramuscular administration of Amevive in Taiwan patients with chronic plaque psoriasis
详细描述
The purpose of the present study is to establish the efficacy and safety of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE in an alternate study population and to address the issue of peak time to response by measuring the proportion of patients achieving a ≥ 75% reduction in PASI at any time after completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Educational Counseling Training
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent
- •Must be >= 16 years of age
- •Must have been diagnosed with chronic plaque psoriasis at least one year and require systemic or phototherapy
- •Must have CD4+ lymphocyte count at or above the lower limit of normal
- •Must have a BSA >= 10%
排除标准
- •Current erythrodermic, generalized pustular, or guttate psoriasis
- •Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- •History of any clinical significant disease that would be contraindicated for this study as determined by the investigator
- •Prior history of systemic malignancy, untreated localised skin canceer or a >10 squamous cell carcinoma
- •Current enrollment in any other investigational drug study within 30 days prior to study drug administration
- •Treatment with systemic immunosuppressant agents within the 4 weeks prior to study drug administration.
结局指标
主要结局
To determine TRR75 of one course of once weekly 15 mg intramuscular (IM) administration of AMEVIVE
次要结局
- To determine TRR50, Quality of Life (QOL), the safety and tolerability
研究者
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