Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis (TYSADIFF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02904876|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : September 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Radiation: Diffusion Magnetic Resonance Imaging at 6 months||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis|
|Actual Study Start Date :||March 2015|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Experimental: 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.
|Radiation: Diffusion Magnetic Resonance Imaging at 6 months|
- Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). [ Time Frame: 24 months ]
- Comparison of different Magnetic Resonance Imaging criteria before and after treatment [ Time Frame: 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904876
|Contact: Jérôme DE SEZEemail@example.com|
|Service de Neurologie Hôpital de Hautepierre||Recruiting|
|Strasbourg, Alsace, France|
|Contact: Jérôme DE SEZE|
|Sub-Investigator: Nicolas COLLONGUES|
|Sub-Investigator: Marie Céline FLEURY|
|Sub-Investigator: Laurent KREMER|
|Principal Investigator:||Jérôme DE SEZE||Service de Neurologie HUS hautepierre|