Evaluation of Early Changes Visible to the Diffusion MRI in Response t
Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Diffusion Magnetic Resonance Imaging at 6 months
Compared with
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
What it measured
Main measures
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
24 months
MRI lesionsCompare diffusion MRI before and after the initiation of treatment with Tysabri (2 years versus baseline) using: the fractional anisotropy in the population of responders and non-responders patients
MRI lesions
Other measures (2)
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
24 months
MRI lesionsCompare diffusion MRI before and after initiation of treatment with Tysabri. In addition to fractional anisotropy (primary endpoint), mean diffusivity and parameters of axial and radial diffusivity will be compared.
MRI lesions
Who could take part
Relapsing MS · 18 and over
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Mar 2015
Main results due
Dec 2019
Finished
May 2020