Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Radiation: Diffusion Magnetic Resonance Imaging at 6 months


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Resonance Imaging at 6 months<br>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. | Radiation: Diffusion Magnetic Resonance Imaging at 6 months<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of different Magnetic Resonance Imaging criteria before and after treatment |  | 24 months |