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

September 11, 2008
November 9, 2012
December 2008
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00752778 on ClinicalTrials.gov Archive Site
Correlation with relapses. [ Time Frame: During the 3 months of treatment and the 3 following months. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic Infiltration in MS Patients Treated With Tysabri
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).

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Sclerosis
Other: pet-scan FDG-F18
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
March 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with MS
  • Treatment with Tysabri planned

Exclusion Criteria:

  • Allergy to Tysabri or MRI contrast products
  • Pregnancy
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00752778
4118
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Biogen Idec
Principal Investigator: Jérôme DE SEZE, MD Hôpitaux universitaires de Strasbourg
University Hospital, Strasbourg, France
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP