A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies

Biogen2 个研究点分布在 1 个国家目标入组 2,000 人开始时间: 2002年7月1日最近更新: 2016年6月16日

适应症

试验速览

阶段: 4 期
状态: 已完成
发起方: Biogen
入组人数: 2,000
试验地点: 2
主要终点: To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.

研究概览研究设计入排标准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

The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
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

•Male and Female Subjects 18 years and older with Crohn's Disease who have participated in studies CD251, CD301, CD303, CD306, or CD307 per protocol

排除标准

未提供

结局指标

主要结局

To evaluate the safety of natalizumab by the number and proportion of subjects with adverse events, and by assessing clinical laboratory parameters and vital signs.

次要结局

未报告次要终点

研究者

发起方

Biogen

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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