AMETYST –  Results of an Observational Phase IV Clinical Study Evaluat­­ing the Ef­fect of Intramuscular Interferon Beta-1a Ther­apy in Patients with Clinical­ly Isolated Syndrome or Clinical­ly Definite Multiple Sclerosis

Authors: P. Štourač 1;  D. Horáková 2;  
e. Klímová 3;  P. Turčáni 4
Authors‘ workplace: Neurologická klinika LF MU a FN Brno 1;  Neurologická klinika a Centrum klinických neurověd 1. LF UK a VFN v Praze 2;  FZ PU a FNsP J. A. Reimana v Prešově 3;  Neurologická klinika 1. LF UK a UN Bratislava 4
Published in: Cesk Slov Neurol N 2017; 80(6): 660-665
Category: Original Paper

Poděkování kolektivu lékařů českých a slovenských MS center a firmě Biogen za provedení klinické studie AMETYST.


AMETYST, a prospective, non-interventional phase IV clinical study, evaluating subjective and objective parameters of 3-year intramuscular interferon beta-1a therapy in patients with clinically isolated syndrome or clinically definite multiple sclerosis.

The primary objective of the study was to evaluate the impact of the study treatment on quality of life assessed by the patient using the visual analogue scale (VAS) and 36-item Short Form Health Survey. Secondary objectives included quality of life assessed using the VAS by the physician, assessment of cognitive functions by the physician using the PASAT test, the occurrence of relapses in the course of the study and the development of clinically definite multiple sclerosis in patients with clinically isolated syndrome, and the evaluation of weekly intramuscular injection administration by patient.

Material and methods:
The study was conducted in centres specialized in the treatment of multiple sclerosis – 14 sites in the Czech Republic and 10 sites in Slovakia. A total of 559 patients were enrolled in the study. Clinical parameters were assessed every six months, the other parameters every 12 months. An analysis of data was performed using descriptive statistic methods. To eliminate the impact of prematurely withdrawn patients on the study results, the data of patients who completed all study visits were analysed separately.

An improvement of the quality of life was detected during the study treatment; however, this improvement was only mild or unconvincing. The quality of life assessed by patient corresponded very well to the quality of life assessed by the physician.

It was confirmed that the treatment has an important effect on relapse rate reduction and stabilization of patients’ clinical status, including their cognitive functions.

Key words:
multiple sclerosis – clinically isolated syndrome – quality of life – cognition – clinical course

The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study.

The Editorial Board declares that the manuscript met the ICMJE “uniform requirements” for biomedical papers.

Chinese summary - 摘要

AMETYST - 观察性IV期临床研究结果评估肌肉干扰素β-1a治疗对临床孤立综合征或临床确诊多发性硬化症患者的影响












多发性硬化 - 临床孤立综合征 - 生活质量 - 认知 - 临床过程


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