Clinical study BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis.
Clinical study No. BCD-132-4/MIRANTIBUS is an international, multicenter, randomized, double-blind, double-masked study using an active reference drug (teriflunomide). The goal of the study is to evaluate the efficacy and safety of BCD-132 in the treatment of patients with relapsing multiple sclerosis. The study includes adults with relapsing-remitting multiple sclerosis (according to 2017 revision to the McDonald Diagnostic Criteria for Multiple Sclerosis) and EDSS disability score up to 5.5. Some of the subjects in this study will be patients rolled over from ongoing phase II clinical study No. BCD-132-2; treatment group, individual product kit number (IPKN), stratification factors, order of procedures and timeframes for blinded therapy with a duration of up to 100 weeks will remain the same.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
336
anti-CD20 monoclonal antibody
Teriflunomide 14 mg
State Budgetary Healthcare Institution of the Moscow Region M.F. Vladimirsky Moscow Regional Research and Clinical Institute
Moscow, Russia
Annualized relapse rate
Annualized relapse rate at 48 weeks after the randomization of the last patient in the study
Time frame: week 48
Proportion of patients with persistent progression
Persistent progression is defined as an increase in the EDSS score from Visit 1 by at least 1.0 in patients with a score \>0 and ≤5.5 at the first visit and by at least 1.5 in patients with a score of 0 at the first visit
Time frame: week 48
Total number of T1 Gd+ lesions
Total number of T1 Gd+ lesions (per scan) detected on brain MRI;
Time frame: week 48
CUA
Combined unique active lesions
Time frame: week 48
Proportion of patients without contrast-enhancing lesions
Proportion of patients without contrast-enhancing lesions
Time frame: week 48
Number of new or enlarged T2 lesions
Number of new or enlarged T2 lesions
Time frame: week 48
Proportion of patients without new or enlarged T2 lesions
Proportion of patients without new or enlarged T2 lesions
Time frame: week 48
Changes in the neurologic deficit according to EDSS score
Changes in the neurologic deficit according to Expanded Disability Status Scale
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Time frame: week 48
Annualized relapse rate
Mean annualized relapse rate
Time frame: week 48
Proportion of patients with adverse reactions
Time frame: week 48
Proportion of patients with serious adverse reactions
Time frame: week 48