Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
Phase 4
Terminated
- Conditions
- Multiple Sclerosis
- Interventions
- Radiation: Diffusion Magnetic Resonance Imaging at 6 months
- Registration Number
- NCT02904876
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Magnetic Resonance Imaging at 6 months Diffusion 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.
- Primary Outcome Measures
Name Time Method Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). 24 months
- Secondary Outcome Measures
Name Time Method Comparison of different Magnetic Resonance Imaging criteria before and after treatment 24 months
Trial Locations
- Locations (1)
Service de Neurologie Hôpital de Hautepierre
🇫🇷Strasbourg, Alsace, France