NL-OMON43550已完成4 期
Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 18 years or older.
- •- Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010.
- •- Natalizumab treatment for 12 months or longer at inclusion.
- •- An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
- •- Natalizumab level more than 15 µg/ml just prior natalizumab infusions for 2 consecutive months.
- •- Written informed consent.
排除标准
- •- Any MS disease activity (radiologically or clinically) during natalizumab treatment, with exclusion of the first three months of treatment.
- •- Unable to undergo frequent MRI.
- •- The use of other immunomodulatory medication other than natalizumab.
研究者
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