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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 August 2016 |
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Main ID: |
NCT02727907 |
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Date of registration:
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29/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple Sclerosis
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Scientific 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 |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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147 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02727907 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Russian Federation
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Placebo
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Drug: Rebif (interferon beta 1a)
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Drug: BCD-033 (interferon beta 1a)
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Primary Outcome(s)
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Number of Combined Unique Active Lesions
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Relapse risk
[Time Frame: 16, 52, 96 weeks]
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Annual relapse rate
[Time Frame: 16, 52, 96 weeks]
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Number of Combined Unique Active Lesions
[Time Frame: 16, 96 weeks]
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Proportion of subjects without confirmed relapse
[Time Frame: 16, 52, 96 weeks]
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Relapse free time
[Time Frame: 16, 52, 96 weeks]
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Secondary ID(s)
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BCD-033-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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