CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 163 enrolled
Drug / intervention
BCD-033 (interferon beta 1a) +2 moredrug
Likely dose
BCD-033 (interferon beta 1a) 44 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02727907
NCT02727907Phase 3Completed
CompareCT.gov

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

Biocad·interventional·Posted Apr 5, 2016·Updated Feb 17, 2023

In Brief

A Phase 3 clinical trial evaluating BCD-033 (interferon beta 1a), Rebif (interferon beta 1a), and 1 other intervention for Multiple Sclerosis. Completed, enrolled 163 participants across 1 site.

Detailed 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®.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartFeb 12, 2015
Primary CompletionNov 21, 2016
Study CompletionAug 11, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.2 years ago

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