NCT00202384终止不适用
Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.
S. Andrea Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2004年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Gene Expression in MS Patients
研究概览
简要总结
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.
Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.
The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •diagnosis of relapsing-remitting MS (McDonald criteria)
- •age between 18-55
- •EDSS less or equal to 5.5
排除标准
- •use of any other disease modifying drugs
- •use of corticosteroids during 3 months before starting protocol
- •clinical relapse during 1 month before starting protocol
- •serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
结局指标
主要结局
Gene Expression in MS Patients
时间窗: baseline and 12 months after IFN beta 1a treatment
Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment
次要结局
未报告次要终点
研究者
Giovanni Ristori
MD
S. Andrea Hospital
研究点 (1)
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