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

Biocad163 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

163

Conditions

Multiple Sclerosis

Interventions

BCD-033 (interferon beta 1a)DRUG

Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks

Rebif (interferon beta 1a)DRUG

Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks

PlaceboDRUG

Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Scientific neurology center, RAS

Moscow, Russia

Outcomes

Primary Outcomes

Number of Combined Unique Active Lesions

Number of Combined Unique Active Lesions (CUA) -- the number of new MRI contrast uptake lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice) after 52 weeks blinded application of interferon-β1а (BCD-033 and Rebif®) (44 mcg).

Time frame: 52 weeks

Secondary Outcomes

Annual Relapse Rate

Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a

Time frame: 52 weeks

Proportion of Subjects Without Confirmed Relapse

proportion of subjects without confirmed relapse in PP

Time frame: 16, 52 weeks

Relapse Free Time

Time to first relapse in "per protocol" population

Time frame: 96 weeks

Number of Combined Unique Active Lesions

CUA (the number of new contrast-enhanced lesions on T1 images, and new or expanding lesions on T2 images (lesion identified on T1-and T2 images is not counted twice)

Time frame: 96 weeks

Annual Relapse Rate

Annual Relapse Rate ARR for 96 weeks was evaluated in two groups, after the administraion of IFN beta-1a in a full dose for 96 weeks.

Time frame: 96 week

Relapse Free Time

Time to first relapse in "per protocol" population

Time frame: 16, 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.