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

Last updated: May 18, 2022
Sponsor: Biocad
Overall Status: Completed

Phase

2/3

Condition

Multiple Sclerosis

Scar Tissue

Memory Loss

Treatment

N/A

Clinical Study ID

NCT02727907
BCD-033-2
  • Ages 18-55
  • All Genders

Study 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®.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 163
Study Start date:
February 12, 2015
Estimated Completion Date:
August 11, 2017

Connect with a study center

  • Scientific neurology center, RAS

    Moscow,
    Russian Federation

    Site Not Available

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