Towards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial)

VU medical center0 个研究点目标入组 60 人开始时间: 2016年4月11日最近更新: 2016年10月10日

适应症

试验速览

暂无简介。

•- 18 years or older.
•- Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010.
•- Natalizumab treatment for 6 months or longer at inclusion.
•- An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
•- Natalizumab level of >10 µg/ml at least 24 weeks after the initiation of natalizumab or later (4 weeks after last dose, 2 consecutive months).
•- 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 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•- 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.

发起方

VU medical center