ACTRN12605000295640进行中（未招募）3 期
An Open-Label, Multicentre Study to Evaluate the Duration of Clinical Remission of Two Courses of Weekly Intramuscular administration of AMEVIVE (alefacept) by evaluating the time to retreatment with AMEVIVE or an alternative systemic therapy in patients with chronic plaque psoriasis in the context of standard dermatological practice
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Biogen Idec
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 16 Years 至 ot stated（—）
- 性别
- All
入选标准
- •1. Must give written informed consent. 2. Must have been diagnosed with chronic plaque psoriasis and require systemic therapy. 3. Must have CD4+ lymphocyte counts at or above the lower limit of normal.
排除标准
- •1. Current erythrodermic, generalized pustular, or guttate psoriasis. 2. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to the first dose of alefacept. 3. History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease that would be contraindicated for this study as determined by the investigator. 4. Prior history of systemic malignancy, untreated localised skin cancer or a >10 squamous cell carcinoma that have been previously treated. 5. Current enrollment in any other investigational drug study within 30 days prior to study drug administration. 6. Current treatment with any therapy for active tuberculosis or tuberculosis prophylaxis. 9. Female patients who are currently pregnant or breast-feeding.
研究者
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