Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis (TYSADIFF)

March 12, 2026 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Alsace
      • Strasbourg, Alsace, France
        • Service de Neurologie Hôpital de Hautepierre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Major Patient
  • 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:

  • Patient not currently eligible for treatment with Tysabri
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Jérôme DE SEZE, Service de Neurologie HUS hautepierre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimated)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5815
  • 2014-003209-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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