临床试验/NCT00454701

NCT00454701终止不适用

Assessment and Tracking of Long-term Alefacept (LFA-3/IgG1 Fusion Protein) Safety (ATLAS)

Astellas Pharma Inc263 个研究点分布在 1 个国家目标入组 1,897 人开始时间: 2003年6月最近更新: 2013年12月11日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: Astellas Pharma Inc
入组人数: 1,897
试验地点: 263
主要终点: To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Subjects exposed to alefacept are to be enrolled. Subjects will be contacted every 6 months to gather general health information.

详细描述

There are no study-mandated tests, visits or clinical interventions after the 1st (enrolling) visit. After the patient is enrolled in the study, they will be contacted every 6 months to complete structured telephone interviews conducted by the ATLAS Study Center.

研究设计

研究类型: Observational
观察模型: Cohort
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

•Psoriasis patients who are prescribed alefacept consistent with product labeling are eligible for enrollment.

排除标准

未提供

研究组 & 干预措施

1. Amevive Exposure

Patients treated with alefacept for chronic plaque psoriasis

干预措施: Alefacept exposure (Drug)

结局指标

主要结局

To measure the rates of non-Hodgkin's lymphoma (NHL) and infections that require hospitalization occurring in psoriasis patients treated with alefacept

时间窗: At six month intervals for five years

次要结局

To estimate the rates of lung cancer, breast cancer (female), prostate cancer, colorectal cancer, melanoma and active tuberculosis within a population of patients with psoriasis treated with alefacept.(At six month intervals for five years)

研究者

发起方

Astellas Pharma Inc

申办方类型

Industry

责任方

Sponsor

研究点 (263)

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