Back to resultsEvaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis (TYSADIFF)
Primary Purpose
Multiple Sclerosis
Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Diffusion Magnetic Resonance Imaging at 6 months
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- Service de Neurologie Hôpital de Hautepierre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magnetic Resonance Imaging at 6 months
Arm Description
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.
Outcomes
Primary Outcome Measures
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
Secondary Outcome Measures
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
Full Information
NCT ID
NCT02904876
First Posted
December 8, 2014
Last Updated
July 24, 2020
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02904876
Brief Title
Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
Acronym
TYSADIFF
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Resonance Imaging at 6 months
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Diffusion Magnetic Resonance Imaging at 6 months
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Comparison of different Magnetic Resonance Imaging criteria before and after treatment
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme DE SEZE
Organizational Affiliation
Service de Neurologie HUS hautepierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Neurologie Hôpital de Hautepierre
City
Strasbourg
State/Province
Alsace
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Early Changes Visible to the Diffusion MRI in Response to Two Years of Treatment With Tysabri in Patients With Multiple Sclerosis
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