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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00752778
• Other study ID #: 4118
• Status: Terminated
• Phase: Phase 4
• First received: September 11, 2008
• Last updated: November 9, 2012
• Start date: December 2008
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with MS

• Treatment with Tysabri planned

Exclusion Criteria:

• Allergy to Tysabri or MRI contrast products

• Pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Other:
• pet-scan FDG-F18

Locations

Country	Name	City	State
France	Service de Médecine Nucléaire, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Service de Radiologie 2, Hôpital de Hautepierre, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Biogen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of enhanced lesions on MRI before and after treatment. PET scan modification in brain (in enhanced lesions and in the whole brain).		At baseline and after 3 months of treatment.	No
Secondary	Correlation with relapses.		During the 3 months of treatment and the 3 following months.	No