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

Study Overview
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Brief Summary
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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®.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: BCD-033 (interferon beta 1a)
* Drug: Rebif (interferon beta 1a)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 Patients of both genders with Multiple Sclerosis (McDonald criteria 2010) No relapses 28 days before randomisation Expanded Disability Status Scale score 0-5,5 Exclusion Criteria Primary or secondary progression of Multiple Sclerosis Expanded Disability Status Scale score more then 5,5 Severe depression, suicide ideas and/or attempts Systemic corticosteroid application in 30 days before randomisation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-033<br>Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks | Drug: BCD-033 (interferon beta 1a)<br>* Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks<br>|
| Active Comparator: Rebif<br>Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks, followed by 48 weeks of open-label BCD-033 usage | Drug: Rebif (interferon beta 1a)<br>* Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks<br>|
| Placebo Comparator: Placebo<br>Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for 48 weeks, followed by 72 weeks of open-label BCD-033 usage | Drug: Placebo<br>* Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annual Relapse Rate | Annual relapse rate ARR for 52 weeks was evaluated in all three groups, after the application of IFN beta-1a | 52 weeks | 
| Proportion of Subjects Without Confirmed Relapse | proportion of subjects without confirmed relapse in PP | 16, 52 weeks | 
| Relapse Free Time | Time to first relapse in per protocol population | 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) | 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. | 96 week | 
| Relapse Free Time | Time to first relapse in per protocol population | 16, 52 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). | 16 weeks |