Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01592474
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2012-05-03
Brief Title:
Evaluation of Brain Atrophy in CIS Patients on Avonex
Sponsor:
University at Buffalo
Organization:
University at Buffalo
Study Overview
Official Title:
Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a IM Treatment in High Risk Subjects After Clinically Isolated Syndrome SET Substudy
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is
To examine if Avaonex can delay the development of clinically definite multiple sclerosis
To investigate if Avonex can delay disability progression by slowing brain atrophy
To examine if Avaonex can delay the development of clinically definite multiple sclerosis
To investigate if Avonex can delay disability progression by slowing brain atrophy
Detailed Description:
Multiple sclerosis MS is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system CNS MRI findings suggest that we should look at gray matter atrophy as a marker of the disease process in MS
Avonex is a proven effective disease-modifying treatment which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS
The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic and are followed with clinical and MRI examinations for 4 years at 0 6 12 24 36 and 48 months The clinical and MRI acquisition examinations of this study are conducted in Czech Republic
Avonex is a proven effective disease-modifying treatment which reduces total brain and GM atrophy and should be considered first-line therapy in patients with RRMS and CIS
The original SET study is an open-label observational study of high risk subjects after CIS for development of CDMS that will enroll 220 patients who have started Avonex immediately after their first clinical attack in Czech Republic and are followed with clinical and MRI examinations for 4 years at 0 6 12 24 36 and 48 months The clinical and MRI acquisition examinations of this study are conducted in Czech Republic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None