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

This study has been terminated.
Sponsor:
Collaborator:
Biogen Idec
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00752778
First received: September 11, 2008
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Multiple Sclerosis
 Other: pet-scan FDG-F18
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MRI Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation with relapses. [ Time Frame: During the 3 months of treatment and the 3 following months. ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752778

Locations
France
Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 37091
Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Biogen Idec
Investigators
Principal Investigator: Jérôme DE SEZE, MD Hôpitaux universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00752778     History of Changes
Other Study ID Numbers: 4118
Study First Received: September 11, 2008
Last Updated: November 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013