ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 15 for:    Tysabri | Recruiting, Not yet recruiting, Available Studies

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02904876
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Radiation: Diffusion Magnetic Resonance Imaging at 6 months Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Comparison of different Magnetic Resonance Imaging criteria before and after treatment [ Time Frame: 24 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02904876     History of Changes
Other Study ID Numbers: 5815
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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