Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

November 9, 2012 updated by: University Hospital, Strasbourg, France

MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

To evaluate the diagnosis value of MRI and positon emission tomography (PET) scan for studying macrophagic infiltration and other brain modification in multiple sclerosis (MS) patients treated with Natalizumab (Tysabri).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 37091
        • Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67098
        • Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
      • Strasbourg, France, 67098
        • Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with MS
  • Treatment with Tysabri planned

Exclusion Criteria:

  • Allergy to Tysabri or MRI contrast products
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).
Time Frame: At baseline and after 3 months of treatment.
At baseline and after 3 months of treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation with relapses.
Time Frame: During the 3 months of treatment and the 3 following months.
During the 3 months of treatment and the 3 following months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

Biogen

Investigators

  • Principal Investigator: Jérôme DE SEZE, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 12, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 12, 2012

Last Update Submitted That Met QC Criteria

November 9, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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