A Phase IV Study to Investigate Differential Immune Effects of Natalizumab

Cantonal Hospital of St. Gallen0 个研究点目标入组 27 人开始时间: 2006年7月最近更新: 2009年3月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Cantonal Hospital of St. Gallen
入组人数: 27
主要终点: Function of T regulatory cells

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

详细描述

Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs).

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 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•relapsing remitting MS
•indication for natalizumab treatment

排除标准

•other disease modifying agents within 2 weeks

结局指标

主要结局

Function of T regulatory cells

时间窗: at month 3

次要结局

Change in distinct immune cell lines(month 3)

研究者

发起方

Cantonal Hospital of St. Gallen

申办方类型

Other

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