Results of an Open-Label Comparative Randomized Clinical Trial of Axoglatiran®  Fs (F-Sintez, Russia) Efficiency and Safety in Comparison With Copaxone®-Teva (Teva Pharmaceutical Industries Ltd., Israel) in Patients With Relapsing-Remitting Multiple Sclerosis

The article discusses the design and results of recently published study of an analog of the original glatiramer acetate. The necessity of the correct planning and analysis of the data of such studies is stressed, showing equal efficacy, tolerability and safety of analog and original drug. The optimal design of such studies, their duration, selection of primary endpoint, adequate assessment of clinical and MRI changes and side-effects are discussed. The authors reckon that it is impossible to plan studies the results of which are based on the design, i.e. the absence of differences from the original drug. The authors invite specialists in MS to participate in the discussion.

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The results of an open comparative retrospective trial of the course of multiple sclerosis during treatment with infibeta and other interferon-beta bioanalogues and glatiramer acetate

Fa¹,

Ti²,

Гранатов

et al. 2018

Z. nevrol. psikhiatr. im. S.S. Korsakova

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Results of an Open-Label Comparative Randomized Clinical Trial of Axoglatiran® Fs (F-Sintez, Russia) Efficiency and Safety in Comparison With Copaxone®-Teva (Teva Pharmaceutical Industries Ltd., Israel) in Patients With Relapsing-Remitting Multiple Sclerosis

Cited by 4 publications

References 6 publications

Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate

Axoglatiran® FS: Generic of Copaxone® Preparation Based on Glatiramer Acetate

An analysis of clinical trials on the registration of similars of the original disease-modifying therapies

The results of an open comparative retrospective trial of the course of multiple sclerosis during treatment with infibeta and other interferon-beta bioanalogues and glatiramer acetate

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