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

Multiple Sclerosis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02904876
• Other study ID #: 5815
• Status: Terminated
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: May 2020

Study information

• Verified date: August 2019
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
France	Service de Neurologie Hôpital de Hautepierre	Strasbourg	Alsace

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).		24 months
Secondary	Comparison of different Magnetic Resonance Imaging criteria before and after treatment		24 months