title: [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].
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Pirogov Russian National Research Medical University, Center of Demielisation Diseases 'Neuroclinic', Moscow, Russia.
authors.forename: A N
authors.initials: AN
authors.lastname: Boyko
authors.affiliation: Pirogov Russian National Research Medical University, City Clinical Hospital #24, Moscow, Russia.
authors.forename: N Yu
authors.initials: NY
authors.lastname: Lashch
authors.affiliation: City Clinical Hospital #24, Moscow, Russia.
authors.forename: S N
authors.initials: SN
authors.lastname: Sharanova
authors.affiliation: Neurology Research Center, Moscow, Russia.
authors.forename: M N
authors.initials: MN
authors.lastname: Zakharova
authors.affiliation: Neurology Research Center, Moscow, Russia.
authors.forename: O V
authors.initials: OV
authors.lastname: Trifonova
authors.affiliation: Neurology Research Center, Moscow, Russia.
authors.forename: T O
authors.initials: TO
authors.lastname: Simaniv
authors.affiliation: Neurology Research Center, Moscow, Russia.
authors.forename: E V
authors.initials: EV
authors.lastname: Lysogorskaya
authors.affiliation: Neurology Research Center, Moscow, Russia.
authors.forename: O E
authors.initials: OE
authors.lastname: Guryanova
authors.affiliation: Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
authors.forename: S V
authors.initials: SV
authors.lastname: Kotov
authors.affiliation: Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
authors.forename: T I
authors.initials: TI
authors.lastname: Iakushina
authors.affiliation: Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
authors.forename: V Yu
authors.initials: VY
authors.lastname: Lizhdvoy
authors.affiliation: Vladimirsky Moscow Regional Research Clinical Institute, Moscow, Russia.
authors.forename: Yu A
authors.initials: YA
authors.lastname: Belova
authors.affiliation: Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
authors.forename: F A
authors.initials: FA
authors.lastname: Khabirov
authors.affiliation: Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
authors.forename: N N
authors.initials: NN
authors.lastname: Babicheva
authors.affiliation: Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
authors.forename: T I
authors.initials: TI
authors.lastname: Khaibullin
authors.affiliation: Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
authors.forename: E V
authors.initials: EV
authors.lastname: Granatov
authors.affiliation: Republican Clinical and Diagnostic Center of Demielisation Diseases, Kazan, Russia.
authors.forename: L A
authors.initials: LA
authors.lastname: Averyanova
authors.affiliation: Unit of Clinical Researches of Multiple Sclerosis of 'Siberian Regional Center', Novosibirsk, Russia.
authors.forename: D V
authors.initials: DV
authors.lastname: Sazonov
authors.affiliation: Kirov Military Medical Academy, St. Petersburg, Russia.
authors.forename: M M
authors.initials: MM
authors.lastname: Odinak
authors.affiliation: Rostov Regional Hospital, Rostov-on-Don, Russia.
authors.forename: Yu V
authors.initials: YV
authors.lastname: Trinitatsky
authors.affiliation: Ochapovsky Regional Clinical Hospital #1, Krasnodar, Russia.
authors.forename: L A
authors.initials: LA
authors.lastname: Tsukurova
authors.affiliation: Ochapovsky Regional Clinical Hospital #1, Krasnodar, Russia.
authors.forename: A I
authors.initials: AI
authors.lastname: Sergeeva
authors.affiliation: JSC BIOCAD, St. Petersburg, Russia.
authors.forename: R A
authors.initials: RA
authors.lastname: Ivanov
authors.affiliation: JSC BIOCAD, St. Petersburg, Russia.
authors.forename: M S
authors.initials: MS
authors.lastname: Shustova
mesh_terms: D004311:Double-Blind Method; D000068717:Glatiramer Acetate / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy*; D010455:Peptides; D012008:Recurrence; D013810:Therapeutic Equivalency
chemical_list: D007166:Immunosuppressive Agents; D010455:Peptides; D000068717:Glatiramer Acetate