Evaluation of Brain Atrophy in CIS Patients on Avonex

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MRI findings must reveal at least 2 hyperintense lesions on T2-WI or FLAIR images at first clinical onset CSF examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the CSF taken before the treatment of attack starts) Age 18 - 55 years Effective contraception in female patients of childbearing potential Kurtzke EDSS ≤ 3.5 at baseline Willingness to accept the plan of the study and compliance with the study Time from the beginning of first symptoms of CIS to baseline visit should not exceed 4 months (baseline MRI and baseline visit will be organized first 28 days after last steroid administration) CIS attack is treated by at least 3g of methylprednisolone without taper In case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first MRI and CSF examination was done before treatment administered No active major organ disease especially of hepatic or thyroid origin Exclusion Criteria: The clinical diagnosis of MS is definite (the second attack occurs before the baseline visit) Age less than 18 or more than 55 Non-effective contraception method or pregnancy planning Active major organ disease, especially hepatic or endocrinologic Cooperation of the subject cannot be ensured Kurtzke EDSS higher than 3.5 at baseline

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can Avonex delay development of clinically definite MS? | To examine whether Avonex can delay the development of clinically definite multiple sclerosis | 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Can Avonex delay disability progression? | To investigate if Avonex can delay disability progression by slowing brain atrophy | 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Avonex, Brain atrophy, MRI, Interferon-beta 1a, IFN Beta 1-a, Clinically isolated syndrome, CIS