EUCTR2019-002566-13-NL进行中（未招募）1 期
Personalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS
Amsterdam University Medical Center0 个研究点目标入组 300 人开始时间: 2019年10月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Diagnosis of relapsing remitting multiple sclerosis according to the 2017 criteria20
- •6 or more consecutive natalizumab infusions
- •18 years or older
- •Agreed to participate (written informed consent)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •High titer natalizumab (>100AU/ml) antibodies
- •Contraindication for frequent magnetic resonance imaging (MRI)
- •Only in the subgroup researching a lower natalizumab trough concentration of 5µg/ml: any disease activity (radiological or clinical) in the past 12 months prior to inclusion
研究者
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