The objective of the clinical study of the medicinal product for medical use: to compare efficacy and safety of the generic drug BCD-063 and Copaxone®-Teva in patients with relapsing-remitting multiple sclerosis. Period of the clinical study of the medicinal product for medical use: from June 10, 2013 to March 23, 2016. Number of patients, involved into the study of the medicinal product for medical use: 158 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
158
Cumulative Unique Activity lesions
Cumulative Unique Activity (CUA) detected by MRI
Time frame: 48 weeks
Annual relapse rate
Relapse per patient per year
Time frame: 48 weeks
Proportion of patients without relapses
Proportion of patients without confirming relapses with magnetic resonance imaging (MRI)
Time frame: 48 weeks
Changing in volume of hypointense T1 lesions
Time frame: 48 weeks
Changing in volume of T2 lesions
Time frame: 48 weeks
Amount of new or extended lesions in T2 regimen
Time frame: 48 weeks
Patients proportion without lesions
Time frame: 48 weeks
T1 lesions amount
Time frame: 48 weeks
Expanded Disability Status Scale dynamics
Expanded Disability Status Scale (EDSS) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group
Time frame: Week 24, Week 48
Progression on Multiple Sclerosis Functional Composite scale comparing to the baseline
Time frame: 48 weeks
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Risk of relapse
Relative Risk Ratio for relapse in each group
Time frame: 48 weeks
Time till the first relapse
Time frame: 48 weeks
Multiple Sclerosis Functional Composite scale dynamics
Multiple Sclerosis Functional Composite (MSFC) scale count at 24th and 48th week, comparing count at week 24 to week 48 for each group
Time frame: 24, 48 weeks