Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
NCT ID: NCT02727907
Last Updated: 2023-02-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
163 participants
INTERVENTIONAL
2015-02-12
2017-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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BCD-033
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
BCD-033 (interferon beta 1a)
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
Rebif
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
Rebif (interferon beta 1a)
Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
Placebo
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
Placebo
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
Interventions
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BCD-033 (interferon beta 1a)
Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
Rebif (interferon beta 1a)
Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
Placebo
Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
ALL
No
Sponsors
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Biocad
INDUSTRY
Responsible Party
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Locations
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Scientific neurology center, RAS
Moscow, , Russia
Countries
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Related Links
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Related Info
Other Identifiers
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BCD-033-2
Identifier Type: -
Identifier Source: org_study_id
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