Magnetic Resonance Imaging (MRI) Follow-up of Macrophagic... | NCT00752778

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

NCT00752778

Sponsor

University Hospital, Strasbourg, France

Status

Terminated

Last Update Posted

Nov 12, 2012Estimated

Enrollment

8Actual

Phase

Phase 4

Conditions

Multiple Sclerosis

Interventions

pet-scan FDG-F18

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 11, 2008

First Submission Date that Met QC Criteria

Sep 12, 2008

First Posted Date

Sep 15, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2012

Last Update Posted Date

Nov 12, 2012Estimated

Name	Class
Biogen	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
pet-scan FDG-F18	Other

Outcomes Module

Primary Outcomes

Measure	Description	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).		At baseline and after 3 months of treatment.

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with MS
Treatment with Tysabri planned

Exclusion Criteria:

Allergy to Tysabri or MRI contrast products
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jérôme DE SEZE, MD	Hôpitaux Universitaires de Strasbourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Neurologie, Hôpital Civil, Hôpitaux Universitaires de Strasbourg		Strasbourg		37091	France

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided