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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003209-14 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Resonance Imaging at 6 months | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Magnetic Resonance Imaging at 6 months | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of different Magnetic Resonance Imaging criteria before and after treatment | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme DE SEZE | Service de Neurologie HUS hautepierre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Neurologie Hôpital de Hautepierre | Strasbourg | Alsace | France |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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