MULTIPLE SCLEROSIS
Conditions
Interventions
Trade Name: TYSABRI 300 mg solution à diluer pour perfusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: NATALIZUMAB
CAS Number: 189261-10-7
Sponsors
Hôpitaux Universitaires de Strasbourg
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Patient not eligible for Tysabri treatment Contraindicayion to MRI Pregnancy (women of childbearing age without effective contraception) Nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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 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 | — |
Countries
France
Contacts
Public ContactDRCI
Hôpitaux Universitaires de Strasbourg
Outcome results
None listed