NCT00819195已完成不适用
Anti-Inflammatory Type II Monocyte Induction by Glatiramer Acetate (Copaxone) Treatment of Multiple Sclerosis
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
- 是
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
研究点 (1)
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