Objective

Interferon Beta-1a - To compare brain MRI outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis treated with two dose-frequencies of subcutaneous interferon beta-1a (44 mg three times a week or once a week) versus placebo over 24 months

Study Summary

Intervention

Subcutaneous interferon beta-1a 44 mg administered either three times a week or once a week for up to 24 months

Inclusion Criteria

Age 18-50 years, EDSS 0.0-5.0, single demyelinating event suggestive of MS within 60 days prior to study entry, ≥2 clinically silent lesions on T2-weighted brain MRI (≥3 mm), at least one ovoid/periventricular/infratentorial

Study Design

Arms: Three parallel arms (1:1:1): IFN β-1a 44 mg SC three times weekly (n=171), IFN β-1a 44 mg SC once weekly (n=175), placebo (n=171)

Patients per Arm: 171 in three times weekly group, 175 in once weekly group, 171 in placebo group

Outcome