Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis

International, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple Sclerosis

Study design is double-blind, randomized, placebo-controlled study in 3 parallel groups with the use of active comparator and placebo. Total duration of therapy of about 2 years. Study hypothesis is equivalence of efficacy and safety of the investigational drug BCD-033 original drug Rebif®.

Inclusion Criteria:

1. Age 18-55
2. Patients of both genders with Multiple Sclerosis (McDonald criteria 2010)
3. No relapses 28 days before randomisation
4. Expanded Disability Status Scale score 0-5,5

Exclusion Criteria

1. Primary or secondary progression of Multiple Sclerosis
2. Expanded Disability Status Scale score more then 5,5
3. Severe depression, suicide ideas and/or attempts
4. Systemic corticosteroid application in 30 days before randomisation