[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]. / Sravnitel'noe platsebo-kontroliruemoe klinicheskoe issledovanie effektivnosti i bezopasnosti preparatov glatiramera atsetata 20 mg u patsientov s remittiruyushchim rasseyannym sklerozom: rezul'taty pervogo goda nablyudeniya.
Zh Nevrol Psikhiatr Im S S Korsakova
; 116(10 Pt 2): 61-67, 2016.
Article
en Ru
| MEDLINE
| ID: mdl-28139613
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 «BIOCAD¼, 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 221, respectively. RESULTS ANDCONCLUSION:
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.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Esclerosis Múltiple Recurrente-Remitente
/
Acetato de Glatiramer
/
Inmunosupresores
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
Ru
Revista:
Zh Nevrol Psikhiatr Im S S Korsakova
Asunto de la revista:
NEUROLOGIA
/
PSIQUIATRIA
Año:
2016
Tipo del documento:
Article
País de afiliación:
Rusia