NCT00692172已完成3 期
An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 175
- 主要终点
- Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
研究概览
简要总结
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
- •Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728
排除标准
- •Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
- •Clinically significant abnormal hematology values or history of an immunosuppressive disorder
- •Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- •A significant change in the subject's medical history from their previous alefacept study
- •Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
- •Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
研究组 & 干预措施
1
Experimental
干预措施: Alefacept (Drug)
结局指标
主要结局
Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring
时间窗: Throughout treatment course
次要结局
- Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment(Every 2 weeks throughout treamtent course)
研究者
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