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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02904876

Acronym

TYSADIFF

Enrollment

Registered

2016-09-19

Start date

2015-03-01

Completion date

2020-05-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

RADIATIONDiffusion 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Comparison of different Magnetic Resonance Imaging criteria before and after treatment	24 months

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJérôme DE SEZE

Service de Neurologie HUS hautepierre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026