Multiple Sclerosis Clinical Trial
Official title:
Effect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.
The primary objective of this study is to define the effect of Tysabri in patients with
relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also
explore the extent of remyelination in MS patients treated with Tysabri over 2 years.
A secondary objective of this study is to investigate differences in the capacity for
remyelination between patients who do or do not respond to Tysabri monotherapy during the
same 24 months.
A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid
antibodies positive and MS antiphospholipid antibodies negative patients and to determine
perfusion differences according to the antiphospholipid antibodies positivity status.
Magnetization transfer imaging (MTI) is a widely used tool for characterizing the evolution
of multiple sclerosis (MS) lesions and normal appearing brain tissue (NABT). As
remyelination and demyelination are heterogeneous in each lesion and NABT, techniques such
as voxel-wise based MTR dynamic mapping may help predict an individual's clinical course, as
well as the effect of treatment, by revealing evidence of myelin repair and neuroprotection.
Natalizumab (Tysabri) showed a robust effect on the decrease of inflammation in phase II and
III clinical trials, as evidenced by the decrease in Gd enhancing and T2 lesions and on the
decrease of clinical activity as measured by reduction of clinical relapses and progression
of disability. The effect of Tysabri on non-conventional measures is only partially known.
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Observational Model: Case Control, Time Perspective: Prospective
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