Clinically isolated syndrome suspected from demyelinating event (no better explanation for present symptoms)
Conditions
Interventions
Trade Name: AVONEX
Product Name: Avonex
Product Code: Interferonum beta-1a
Pharmaceutical Form: Solution for injection
Sponsors
DSC Services, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Clinically isolated syndrome suspected from demyelinating event (no better explanation for present symptoms) · First diagnostic MRI must be done before steroid treatment, with 3 mm slices without gap, without and with gadolinium, at least T1W and T2W images must be provided. · MRI findings must reveal at least 2 hyperintense lesions on T2W or FLAIR images · CSF examination confirms 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, inclusive · Effective contraception in female patients of childbearing potential · Kurtzke EDSS = 3.5 at baseline, in an acute attack does not exceed 6. · 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 does not exceeds 4 months (baseline MRI and baseline visit can be organized first 28 days after last steroid administration) · CIS was 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · The clinical diagnosis of Multiple Sclerosis is definite (the second attack occurs before the baseline visit) · Active major organ disease, especially hepatic or endocrinologic · Allergy to gadolinium · History of alcohol or drug abuse within 2 years prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine which high-risk patient groups presenting with a clinically isolated syndrome (CIS) suggestive of multiple sclerosis may have the best clinical outcome from treatment with interferon beta 1-a (Avonex). This study will evaluate the conversion pattern to clinically definite multiple sclerosis in high risk CIS patients treated with (IFN beta-1a IM) (Avonex) during a follow up period of 4 years and will determine risk factors for conversion to CDMS under treatment. Each clinical and MRI end point will be evaluated with its relation to the baseline clinical and MRI characteristics.;Secondary Objective: To evaluate longitudinal quality of life, ability to work and development of cognitive impairment in this early MS population and to explore: - the development of T2W lesion volume (measured on the FLAIR sequence) on yearly brain MRI scans; - the development of T1W lesion volume on yearly brain MRI scans; - the development of the total brain MTR on yearly brain MRI scans; - the development of brain atrophy on T1 and FLAIR sequences on yearly brain MRI scans; - the volume of Gd enhancing lesions on yearly brain MRI scans - the development of cognitive functions in early MS judged by PASAT test - the development of serum antibodies against myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) during the time of the study and correlation with clinical and MRI markers; - production and change in production of intracellular cytokines in peripheral lymphocytes and monocytes; ;Primary end point(s): Clinical endpoints include: - the occurance of clinical relapses; - the delay in conversion to Clinically Definite Multiple Sclerosis; - the delay in development of Multiple Sclerosis as defined by McDonald´s criteria (2001); - the delay in the progression of disability defined as at least 1.0 point increase on EDSS from baseline EDSS = 1.0, that is sustained for 6 months, or at least a 1.5 point increase on the EDSS from basel | — |
Countries
Czech Republic
Outcome results
None listed