Evaluation of Brain Atrophy in CIS Patients on Avonex

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01592474

Enrollment

180

Registered

2012-05-07

Start date

2005-10-31

Completion date

2012-06-30

Last updated

2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Avonex, Brain atrophy, MRI, Interferon-beta 1a, IFN Beta 1-a, Clinically isolated syndrome, CIS

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Can Avonex delay disability progression?	5	To investigate if Avonex can delay disability progression by slowing brain atrophy

Outcome results