Towards Personalized Dosing of Natalizumab in Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 5
- 主要终点
- Gadolinium enhancing T1 lesions on brain MRI
研究概览
简要总结
A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.
详细描述
Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 of ≥15 μg/ml
- •Written informed consent.
排除标准
- •Any MS disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment.
- •Unable to undergo frequent MRI.
- •The use of other immunomodulatory medication other than natalizumab.
研究组 & 干预措施
All patients in this study
Patients treated with natalizumab with a minimum of 1 year, without signs of disease activity (relapses, new T2 lesions on MRI) for a minimum of 1 year.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Gadolinium enhancing T1 lesions on brain MRI
时间窗: 12 months
Occurrence and number of gadolinium enhancing T1 lesions of brain MRI
次要结局
- EDSS(12 months)
- MSFC(baseline and 12 months)
- patient perspective measured with the MSIS-29(baseline and 12 months)
- New T2 lesions on brain MRI(12 months)
- Relapses(12 months)
- patient perspective measured with the SF-36(baseline and 12 months)
研究者
Zoé van Kempen
Coordinating investigator
Amsterdam UMC, location VUmc