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Boĭko A.N.

KGBUZ "Krasnoiarskiĭ kraevoĭ Tsentr po profilaktike i bor'be so SPID i infektsionnymi zabolevaniiami"

Lashch N.Iu.

Kafedra nevrologii i neĭrokhirurgii Rossiĭskogo natsional'nogo issledovatel'skogo meditsinskogo universiteta

Sharanova S.N.

Kafedra nevrologii i neĭrokhirurgii Rossiĭskogo natsional'nogo issledovatel'skogo meditsinskogo universiteta

Zakharova M.N.

Nauchnyĭ tsentr nevrologii RAMN, Moskva

Trifonova O.V.

Research Center of Neurology, Moscow

Simaniv T.O.

Neurology Research Center, Moscow

Lysogorskaya E.V.

Neurology Research Center, Moscow, Russia

Gur'ianova O.E.

Kotov S.V.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Iakushina T.I.

Lizhdvoĭ V.Iu.

Belova Iu.A.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Khabirov F.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Babicheva N.N.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Khaĭbullin T.I.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Granatov E.V.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Aver'ianova L.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Sazonov D.V.

FGBU "Federal'nyĭ nauchno-klinicheskiĭ tsentr spetsializirovannykh vidov meditsinskoĭ pomoshchi i meditsinskikh tekhnologiĭ FMBA Rossii", Moskva

Odinak M.M.

Kafedra nervnykh bolezneĭ Voenno-meditsinskoĭ akademii im. S.M. Kirova, Sankt-Peterburg

Trinitatskiĭ Iu.V.

GBUZ "Rostovskaia oblastnaia klinicheskaia bol'nitsa", Rostov-na-Donu

Tsukurova L.A.

Kraevaia klinicheskaia bol'nitsa #1 im. prof. S.V. Ochapovskogo, Krasnodar

Sergeeva A.I.

Ochapovsky Regional Clinical Hospital №1, Krasnodar, Russia

Ivanov R.A.

JSC BIOCAD, St. Petersburg, Russia

Shustova M.S.

JSC BIOCAD, St. Petersburg, Russia

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

Authors:

Boĭko A.N., Lashch N.Iu., Sharanova S.N., Zakharova M.N., Trifonova O.V., Simaniv T.O., Lysogorskaya E.V., Gur'ianova O.E., Kotov S.V., Iakushina T.I., Lizhdvoĭ V.Iu., Belova Iu.A., Khabirov F.A., Babicheva N.N., Khaĭbullin T.I., Granatov E.V., Aver'ianova L.A., Sazonov D.V., Odinak M.M., Trinitatskiĭ Iu.V., Tsukurova L.A., Sergeeva A.I., Ivanov R.A., Shustova M.S.

More about the authors

Journal: S.S. Korsakov Journal of Neurology and Psychiatry. 2016;116(10‑2): 61‑67

DOI: 10.17116/jnevro201611610261-67

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Table of contents

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
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

To cite this article:

Boĭko AN, Lashch NIu, Sharanova SN, et al. . 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. S.S. Korsakov Journal of Neurology and Psychiatry. 2016;116(10‑2):61‑67. (In Russ.)
https://doi.org/10.17116/jnevro201611610261-67

Подписка 2025-2 (S.S. Korsakov Journal of Neurology and Psychiatry (special issues))
 
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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.

Keywords:

relapsing-remitting multiple sclerosis
glatiramer acetate
BCD-063

Authors:

Boĭko A.N.

KGBUZ "Krasnoiarskiĭ kraevoĭ Tsentr po profilaktike i bor'be so SPID i infektsionnymi zabolevaniiami"

Lashch N.Iu.

Kafedra nevrologii i neĭrokhirurgii Rossiĭskogo natsional'nogo issledovatel'skogo meditsinskogo universiteta

Sharanova S.N.

Kafedra nevrologii i neĭrokhirurgii Rossiĭskogo natsional'nogo issledovatel'skogo meditsinskogo universiteta

Zakharova M.N.

Nauchnyĭ tsentr nevrologii RAMN, Moskva

Trifonova O.V.

Research Center of Neurology, Moscow

Simaniv T.O.

Neurology Research Center, Moscow

Lysogorskaya E.V.

Neurology Research Center, Moscow, Russia

Gur'ianova O.E.

Kotov S.V.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Iakushina T.I.

Lizhdvoĭ V.Iu.

Belova Iu.A.

Moskovskiĭ oblastnoĭ nauchno-issledovatel'skiĭ klinicheskiĭ institut im. M.F. Vladimirskogo

Khabirov F.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Babicheva N.N.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Khaĭbullin T.I.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Granatov E.V.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Aver'ianova L.A.

Kazanskaia gosudarstvennaia meditsinskaia akademiia Minzdravsotsrazvitiia Rossii;
Respublikanskiĭ kliniko-diagnosticheskiĭ tsentr po demieliniziruiushchim zabolevaniiam Ministerstva zdravookhraneniia Respubliki Tatarstan, Kazan'

Sazonov D.V.

FGBU "Federal'nyĭ nauchno-klinicheskiĭ tsentr spetsializirovannykh vidov meditsinskoĭ pomoshchi i meditsinskikh tekhnologiĭ FMBA Rossii", Moskva

Odinak M.M.

Kafedra nervnykh bolezneĭ Voenno-meditsinskoĭ akademii im. S.M. Kirova, Sankt-Peterburg

Trinitatskiĭ Iu.V.

GBUZ "Rostovskaia oblastnaia klinicheskaia bol'nitsa", Rostov-na-Donu

Tsukurova L.A.

Kraevaia klinicheskaia bol'nitsa #1 im. prof. S.V. Ochapovskogo, Krasnodar

Sergeeva A.I.

Ochapovsky Regional Clinical Hospital №1, Krasnodar, Russia

Ivanov R.A.

JSC BIOCAD, St. Petersburg, Russia

Shustova M.S.

JSC BIOCAD, St. Petersburg, Russia

List of references:

  1. Zabolevaemost' vsego naselenija Rossii v 2014 g. Statisticheskie materialy MZ RF. Accessed June 15, 2016. Available at: https://www.rosminzdrav.ru/documents/9479-statisticheskaya-informatsiya-za-2014 (In Russ.).
  2. Rassejannyj skleroz. Klinicheskoe rukovodstvo. Pod red. Guseva E.I., Zavalishina I.A., Boyko A.N. M.: Real Tajm; 2011. (In Russ.).
  3. Approval package for application number: NDA 20-622/S-015. Center for drug evaluation and research FDA. July 12, 2001. Accessed June 15, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf
  4. Copaxone (glatiramer acetate for injection) new drug application for FDA NDA 20-622/S-015/S-015. 2001. Accessed June 15, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf

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