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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT02904876
First received: December 8, 2014
Last updated: September 13, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Radiation: Diffusion Magnetic Resonance Imaging at 6 months
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • Comparaison of diffusion Magnetic Resonance Imaging before and after the initiation of treatment with Tysabri using fractional anisotropy (FA). [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of different Magnetic Resonance Imaging criteria before and after treatment [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2015
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02904876

Contacts
Contact: Jérôme DE SEZE jerome.de.seze@chru-strabourg.fr

Locations
France
Service de Neurologie Hôpital de Hautepierre Recruiting
Strasbourg, Alsace, France
Contact: Jérôme DE SEZE         
Sub-Investigator: Nicolas COLLONGUES         
Sub-Investigator: Marie Céline FLEURY         
Sub-Investigator: Laurent KREMER         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Jérôme DE SEZE Service de Neurologie HUS hautepierre
  More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02904876     History of Changes
Other Study ID Numbers: 5815 
Study First Received: December 8, 2014
Last Updated: September 13, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Natalizumab
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016