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Zh Nevrol Psikhiatr Im S S Korsakova. 2016;116(10 Pt 2):61-67. doi: 10.17116/jnevro201611610261-67.

[Comparative, placebo-controlled clinical study of efficacy and safety of glatiramer acetate 20 mg in patients with relapsing-remitting multiple sclerosis: results of the first year of the study].

[Article in Russian; Abstract available in Russian from the publisher]

Author information

1
Pirogov Russian National Research Medical University, Center of Demielisation Diseases 'Neuroclinic', Moscow, Russia.
2
Pirogov Russian National Research Medical University, City Clinical Hospital #24, Moscow, Russia.
3
City Clinical Hospital #24, Moscow, Russia.
4
Neurology Research Center, Moscow, Russia.
5
Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
6
Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
7
Unit of Clinical Researches of Multiple Sclerosis of 'Siberian Regional Center', Novosibirsk, Russia.
8
Kirov Military Medical Academy, St. Petersburg, Russia.
9
Rostov Regional Hospital, Rostov-on-Don, Russia.
10
Ochapovsky Regional Clinical Hospital #1, Krasnodar, Russia.
11
JSC BIOCAD, St. Petersburg, Russia.

Abstract

in English, Russian, Russian

The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD», Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) in patients with relapsing-remitting multiple sclerosis.

METHODS:

158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: BCD-063, copaxone-Teva and placebo, at a ratio of 2:2:1, respectively.

RESULTS AND CONCLUSION:

Efficacy analysis after 48 weeks of therapy demonstrated no differences between BCD-063 group and copaxone-Teva group in both MRI parameters and frequency of relapses. The mean (SD) of number of MRI-confirmed relapses per patient per year (the primary endpoint) in BCD-063 group was 0.098361 (0.351422), in copaxone-Teva group - 0.098361 (0, 351 422) and in placebo group - 0.178571 (0.390021). There were also no differences between the groups for all other efficacy parameters (EDSS and MSFC). Both investigational BCD-063 and copaxone-Teva demonstrated a favorable safety profile. The data obtained from the present study confirm the therapeutic equivalence of BCD-063 (CJSC BIOCAD, Russia) and copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.

PMID:
28139613

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