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

NCT02904876 | Terminated Phase 4

• 2 other identifiers: 58152014-003209-14
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA).

  24 months

Secondary Outcomes (1)

• Comparison of different Magnetic Resonance Imaging criteria before and after treatment

  24 months

Study Arms (1)

Magnetic Resonance Imaging at 6 months

EXPERIMENTAL

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

Interventions

Diffusion Magnetic Resonance Imaging at 6 months RADIATION

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.

Magnetic Resonance Imaging at 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Neurologie Hôpital de Hautepierre

Strasbourg, Alsace, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jérôme DE SEZE

  Service de Neurologie HUS hautepierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: September 19, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: March 16, 2026

Record last verified: 2019-08

Locations

FR (1)