Observational Study of Early Interferon beta 1-a Treatment in High Risk Subjects after CIS (SET Study) - SET Study

• Conditions: Clinically isolated syndrome suspected from demyelinating event (no better explanation for present symptoms)

• Registration Number: EUCTR2005-001281-13-CZ
• Lead Sponsor: DSC Services, s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-08
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

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

· 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified