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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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®.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

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