Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
研究概览
简要总结
Through this phase IV study, multicenter prospective exploratory, uncontrolled, the investigators propose to identify MRI predictive factors of treatment response, using diffusion MRI sequences, in addition to conventional sequences.
The primary objective is to study the links between changes on MRI diffusion and response to treatment with Tysabri to 2 years.
The secondary objective is to compare the evolution of diffusion MRI data with the volumetric MRI data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Major Patient
- •Patient with relapsing remitting multiple sclerosis and eligible for treatment with Tysabri
- •Patient affiliated to a social security scheme
- •Patient who signed informed consent
- •Patient who have been informed of the results of the prior medical examination
排除标准
- •Patient not currently eligible for treatment with Tysabri
- •Contraindication to MRI scanning
- •Unability to provide informed consent (subject in an emergency situation, difficulties in understanding , ...)
- •Patient under judicial protection
- •Patient under guardianship or curatorship
- •Pregnancy (women of childbearing age in the absence of effective contraception)
- •Breastfeeding
研究组 & 干预措施
Magnetic Resonance Imaging at 6 months
2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI.
干预措施: Diffusion Magnetic Resonance Imaging at 6 months (Radiation)
结局指标
主要结局
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
时间窗: 24 months
次要结局
- Comparison of different Magnetic Resonance Imaging criteria before and after treatment(24 months)