NCT00795353终止不适用
Amevive Wisdom Acquired Through Real-world Evidence - 2 (A.W.A.R.E.-2) Program: Long-Term Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 主要终点
- Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
研究概览
简要总结
The study is a prospective, multi-centre, observational study designed to assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis.
详细描述
Study includes a bio-marker sub-study to determine differences in responders vs. non-responders. Additional consent is required for the sub-study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects with moderate to severe chronic plaque psoriasis who receive a new prescription for alefacept
排除标准
- •Subjects with a contraindication to alefacept
- •Subjects with a history of cancer except for adequately treated basal cell carcinoma (maximum of 2 lesions)
- •Subjects with any active cancer, including skin cancer
- •Subjects having a serious local infection (eg. cellulitis, abscess) or serious systemic infection (eg. pneumonia, septicemia, tuberculosis), within the 3 months prior to the first dose of alefacept.
- •Subjects known to be infected with the AIDS virus
研究组 & 干预措施
1. Amevive Exposure
Canadian subjects with moderate to severe chronic plaque psoriasis
干预措施: Amevive exposure (Drug)
结局指标
主要结局
Assess the long-term effectiveness and safety of alefacept in subjects with moderate to severe chronic plaque psoriasis
时间窗: 8 Weeks following last dose of each treatment course throughout study
次要结局
- Assess the quality of life of subjects on alefacept based on completion of the Dermatology Life Quality Index(8 Weeks following last dose of each treatment course throughout study)
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