NCT00233662已完成3 期
An Open-Label, Multicenter Study to Evaluate the Safety and Tolerability of Repeat Courses of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Patients With Chronic Plaque Psoriasis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 400
- 试验地点
- 90
- 主要终点
- Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
研究概览
简要总结
The purpose of this study is to determine whether repeat courses of alefacept, administered intramuscularly, are safe when given to chronic plaque psoriasis patients who are receiving standard dermatology treatments.
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
- Treatment
- 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
- •Written informed consent.
- •At least 16 years of age.
- •Diagnosed with chronic plaque psoriasis and require systemic therapy.
- •CD4+ lymphocyte counts at or above the lower limit of normal for Covance Central Laboratory Services, Inc., unless on a stable dose of prednisone (counts must be at or above 300 cells/mm3).
排除标准
- •Unstable erthrodermic or pustular psoriasis.
- •Diagnosis of guttate psoriasis.
- •Serious local infection or systemic infection within 3 months prior to first dose of alefacept.
- •Positive for HIV antibody.
- •Known invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
- •Evidence of active tuberculosis.
- •Current treatment for active tuberculosis or tuberculosis prophylaxis.
- •Female patients unwilling to practice effective contraception as defined by the investigator.
- •Female patients who are pregnant or breast-feeding.
- •Current enrollment in any other investigational drug study.
- •Previous participation in this study or previous alefacept studies.
结局指标
主要结局
Incidence of infections, malignancies, serious adverse events, adverse events leading to discontinuation of study drug, dose withholding (due to infection or decreased T cells), and changes in lymphocyte counts over time.
次要结局
- Patients who achieve a Physician Global Assessment (PGA) of "almost clear" or "clear" over time; the duration of the response to alefacept (the amount of time after alefacept treament before re-treatment with alefacept is necessary).
研究者
研究点 (90)
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