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Neuroscience and Behavioral Physiology

, Volume 48, Issue 3, pp 351–357 | Cite as

A Comparative Placebo-Controlled Clinical Trial of the Efficacy and Safety of Glatiramer Acetate 20 mg in Patients with Remitting Multiple Sclerosis: First-Year Study Results

  • A. N. Boiko
  • N. Yu. Lashch
  • S. N. Sharanova
  • M. N. Zakharova
  • O. V. Trifonova
  • T. O. Simaniv
  • E. V. Lysogorskaya
  • O. E. Gur’yanova
  • S. V. Kotov
  • T. I. Yakushina
  • V. Yu. Lizhdvoi
  • Yu. A. Belova
  • F. A. Khabirov
  • N. N. Babicheva
  • T. I. Khaibullin
  • E. V. Granatov
  • L. A. Aver’yanova
  • D. V. Sazonov
  • M. M. Odinak
  • Yu. V. Trinitatskii
  • L. A. Tsukurova
  • A. I. Sergeeva
  • R. A. Ivanov
  • M. S. Shustova
Article
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Objective. To seek evidence that Timexon (BCD-063, glatiramer acetate, Biocad, Russia) and Copaxone-Teva (Teva Pharmaceuticals Ltd., Israel) have similar efficacies in patients with remitting multiple sclerosis. Materials and methods. A multicenter, double-blind, placebo-controlled, comparative, randomized, phase III study included 158 patients with confirmed diagnoses of remitting multiple sclerosis. Patients were randomized to the BCD-063, Copaxone-Teva, and placebo groups at a ratio of 2:2:1. Results and conclusions. Efficacy analysis at 48 weeks of treatment demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups in terms of MRI parameters or exacerbation frequency. Assessment of the primary endpoint (number of MRI-confirmed exacerbations per patient per year) showed that the mean number of exacerbations was 0.098361 (0.351422) in the BCD-063 group, 0.098361 (0.351422) in the Copaxone-Teva group, and 0.178571 (0.390021) in the placebo group. Assessments on the EDSS and MSFC also demonstrated that there were no differences between the BCD-063 and Copaxone-Teva groups. Both BCD-063 and Copaxone-Teva had favorable safety profiles. These data provide evidence of the therapeutic equivalence of BCD-063 (Biocad, Russia) and Copaxone-Teva, which is an important aspect for further introduction of the reproduced glatiramer acetate formulation into the treatment of multiple sclerosis.

Keywords

remitting multiple sclerosis glatiramer acetate BCD-063 

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References

  1. 1.
    Morbidity of the Whole Population of Russia in 2014. Statistical Data from the Ministry of Health of the Russian Federation, https:/ www.rosminzdrav.ru/documents/9479-statisticheskaya-informatsiyaza-2014, acc. June 15, 2016.
  2. 2.
    E. I. Gusev, I. A. Zavalishin, and A. N. Boiko (eds.), Multiple Sclerosis. Clinical Guidelines, Real Time, Moscow (2011).Google Scholar
  3. 3.
    Approval package for application number: NDA 20-622/S-015. Center for Drug Evaluation and Research FDA, July 12, 2001, www. accessdata.fda.gov/drugsatfda_docs/nda/2001/020622_S015_COPAXONE_INJECTION_AP.pdf, acc. June 15, 2016.
  4. 4.
    Copaxone (glatiramer acetate for injection). New Drug Application for FDA NDA 20-622/S-015/S-015. 2001, www.accessdata.fda.gov/drugsatfda_docs/label/2001/20622s15lbl.pdf, acc. June 15, 2016.

Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • A. N. Boiko
    • 1
  • N. Yu. Lashch
    • 2
  • S. N. Sharanova
    • 3
  • M. N. Zakharova
    • 4
  • O. V. Trifonova
    • 4
  • T. O. Simaniv
    • 4
  • E. V. Lysogorskaya
    • 4
  • O. E. Gur’yanova
    • 4
  • S. V. Kotov
    • 5
  • T. I. Yakushina
    • 5
  • V. Yu. Lizhdvoi
    • 5
  • Yu. A. Belova
    • 5
  • F. A. Khabirov
    • 6
  • N. N. Babicheva
    • 6
  • T. I. Khaibullin
    • 6
  • E. V. Granatov
    • 6
  • L. A. Aver’yanova
    • 6
  • D. V. Sazonov
    • 7
  • M. M. Odinak
    • 8
  • Yu. V. Trinitatskii
    • 9
  • L. A. Tsukurova
    • 10
  • A. I. Sergeeva
    • 10
  • R. A. Ivanov
    • 11
  • M. S. Shustova
    • 11
  1. 1.Pirogov Russian National Research Medical University; Neiroklinika Center for Demyelinating DiseasesMoscowRussia
  2. 2.Pirogov Russian National Medical Research University; City Clinical Hospital No. 24, Moscow Department of HealthMoscowRussia
  3. 3.City Clinical Hospital No. 24, Moscow Department of HealthMoscowRussia
  4. 4.Neurology Scientific CenterRussian Academy of SciencesMoscowRussia
  5. 5.Vladimirskii Moscow Regional Research Clinical InstituteMoscowRussia
  6. 6.Republican Clinical Neurology CenterMinistry of Health of the Republic of TatarstanKazanRussia
  7. 7.Siberian District Medical CenterFederal Medical-Biological AgencyNovosibirskRussia
  8. 8.Kirov Military Medical AcademySt. PetersburgRussia
  9. 9.Rostov Regional Clinical HospitalRostov-on-DonRussia
  10. 10.Ochapovskii District Clinical Hospital No. 1Krasnodar Regional Ministry of HealthKrasnodarRussia
  11. 11.Biocad CompanySt. PetersburgRussia

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