ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS
- Conditions
- MULTIPLE SCLEROSISTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-003209-14-FR
- Lead Sponsor
- Hôpitaux Universitaires de Strasbourg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patient > 18
Patient with Multiple Sclerosis in the relapsing form and eligible for Tysabri treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
Patient not eligible for Tysabri treatment
Contraindicayion to MRI
Pregnancy (women of childbearing age without effective contraception)
Nursing
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To study the links between early changes visible on diffusion MRI and response to treatment with Tysabri for 2 years;Secondary Objective: Compare the evolution of diffusion MRI data to volumetric data;Primary end point(s): Compare 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;Timepoint(s) of evaluation of this end point: 2 years after the initiation of Tysabri treatment
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Compare 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. <br>The data of MRI follow-up will be analyzed and the following criteria will be studied: total brain volume, volume of white and gray matter, total volume of FLAIR hyper intensity, number of gadolinium-enhancing lesions on T1-weighted and maps coefficients apparent diffusion (ADC) and anisotropy of the white matter <br>Correlation of the evoloution of data diffusion MRI (FA and ADC) to the evolution of volumetric data in T1 and the evolution of volumetric data hyperintensity on FLAIR sequence;Timepoint(s) of evaluation of this end point: 2 years after the initiation of Tysabri treatment