Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
NCT ID: NCT02904876
Last Updated: 2020-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
70 participants
INTERVENTIONAL
2015-03-31
2020-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Magnetic Resonance Imaging at 6 months
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.
Diffusion Magnetic Resonance Imaging at 6 months
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.
Interventions
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Diffusion Magnetic Resonance Imaging at 6 months
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Jérôme DE SEZE
Role: PRINCIPAL_INVESTIGATOR
Service de Neurologie HUS hautepierre
Locations
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Service de Neurologie Hôpital de Hautepierre
Strasbourg, Alsace, France
Countries
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Other Identifiers
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5815
Identifier Type: -
Identifier Source: org_study_id
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