Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis (TYSADIFF)
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.
|Multiple Sclerosis||Radiation: Diffusion Magnetic Resonance Imaging at 6 months||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis|
- Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). [ Time Frame: 24 months ]
- Comparison of different Magnetic Resonance Imaging criteria before and after treatment [ Time Frame: 24 months ]
|Actual Study Start Date:||March 2015|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Radiation: Diffusion Magnetic Resonance Imaging at 6 months|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02904876
|Contact: Jérôme DE SEZEfirstname.lastname@example.org|
|Service de Neurologie Hôpital de Hautepierre||Recruiting|
|Strasbourg, Alsace, France|
|Contact: Jérôme DE SEZE|
|Sub-Investigator: Nicolas COLLONGUES|
|Sub-Investigator: Marie Céline FLEURY|
|Sub-Investigator: Laurent KREMER|
|Principal Investigator:||Jérôme DE SEZE||Service de Neurologie HUS hautepierre|