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

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 4

Conditions: Multiple Sclerosis

Treatments: Radiation: Diffusion Magnetic Resonance Imaging at 6 months

Study type: Interventional

Funder types: Other

Identifiers

NCT02904876

5815

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Magnetic Resonance Imaging at 6 months

Experimental group

Description:

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.

Treatment:

Radiation: Diffusion Magnetic Resonance Imaging at 6 months