Evaluation of Brain Atrophy in CIS Patients on Avonex
|ClinicalTrials.gov Identifier: NCT01592474|
Recruitment Status : Completed
First Posted : May 7, 2012
Last Update Posted : July 9, 2014
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.
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||180 participants|
|Official Title:||Evolution of Gray Matter Atrophy Over 4 Years in Observational Study of Early IFNβ-1a I.M. Treatment in High Risk Subjects After Clinically Isolated Syndrome (SET Substudy)|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||June 2012|
- Can Avonex delay development of clinically definite MS? [ Time Frame: 5 ]To examine whether Avonex can delay the development of clinically definite multiple sclerosis
- Can Avonex delay disability progression? [ Time Frame: 5 ]To investigate if Avonex can delay disability progression by slowing brain atrophy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592474
|Principal Investigator:||Robert Zivadinov, MD,PhD,FAAN||University at Buffalo|