跳至主要内容
临床试验/NCT00819195
NCT00819195已完成不适用

Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Production of inflammatory cytokines by monocytes and naive T cells.

研究概览

简要总结

The purpose of this study is to determine whether glatiramer acetate (Copaxone) will induce anti-inflammatory type II monocyte development during treatment of MS, and if these antigen presenting cells (APC) will promote Th2 and Treg differentiation of naïve T cells.

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 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Relapsing-remitting (RR) MS patients (McDonald criteria)
  • Ages 18-55
  • Males and females
  • EDSS score ≤5
  • No prior treatment with Copaxone
  • Prior treatment with corticosteroids or interferon-beta (-1a or -1b) is acceptable, provided there is a washout period of at least one month

排除标准

  • Treatment with Tysabri, Novantrone or cyclophosphamide
  • Treatment with other immunomodulatory therapies (e.g. imuran, mycophenolate or methotrexate)
  • Primary-progressive (PP) and secondary-progressive (SP) multiple sclerosis
  • Pregnancy

研究组 & 干预措施

RRMS

Relapsing-remitting multiple sclerosis patients who have not yet received glatiramer acetate (Copaxone) therapy recommended as part of clinical care

干预措施: Glatiramer acetate (Drug)

结局指标

主要结局

Production of inflammatory cytokines by monocytes and naive T cells.

时间窗: 0, 1, 2, 4, 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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