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

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ClinicalTrials.gov Identifier: NCT00752778
Recruitment Status : Terminated
First Posted : September 15, 2008
Last Update Posted : November 12, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Other: pet-scan FDG-F18 Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
Study Start Date : December 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Correlation with relapses. [ Time Frame: During the 3 months of treatment and the 3 following months. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with MS
  • Treatment with Tysabri planned

Exclusion Criteria:

  • Allergy to Tysabri or MRI contrast products
  • Pregnancy
Contacts and Locations

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): NCT00752778


Locations
France
Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 37091
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
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Biogen
Investigators
Principal Investigator: Jérôme DE SEZE, MD Hôpitaux universitaires de Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00752778     History of Changes
Other Study ID Numbers: 4118
First Posted: September 15, 2008    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012

Keywords provided by University Hospital, Strasbourg, France:
MRI, PET scan

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