Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment
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
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Placebo
- Placebo
Results by group
Number of Combined Unique Active Lesions
52 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BCD-033 | 0.0 lesions | 0–1.25 | 44 |
| Rebif | 0.0 lesions | 0–1 | 46 |
BCD-033
Rebif
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| BCD-033 | 53 | 0 (0.0%) | 0 |
| Rebif | 55 | 0 (0.0%) | 0 |
| Placebo/BCD-033 | 54 | 2 (3.7%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Combined Unique Active Lesions
52 weeks
MRI lesionsImmune response
Other measures (7)
Annual Relapse Rate
52 weeks
RelapsesProportion of Subjects Without Confirmed Relapse
16, 52 weeks
RelapsesRelapse Free Time
96 weeks
RelapsesNumber of Combined Unique Active Lesions
96 weeks
MRI lesionsAnnual Relapse Rate
96 week
RelapsesRelapse Free Time
16, 52 weeks
RelapsesNumber of Combined Unique Active Lesions
16 weeks
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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®.
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History
Started
Feb 2015
Main results due
Nov 2016
Finished
Aug 2017
Results posted
Feb 2023