Early diagnosis of ankylosing spondylitis: assessment the criteria for axial spondyloarthritis, proposedby the International Working Group of the Assessment of SpondyloArthritis Society (ASAS)

Бочкова, А. Г.; Левшакова, А. В.; Бунчук, Н В

doi:10.14412/1995-4484-2010-1414

Cited by 1 publication

(3 citation statements)

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“…В КИ может быть использована оценка по критериям ASAS (ASAS 20, ASAS 40), которые определяются как улучшение не менее чем на 20 или 40% соответственно, по крайней мере трех из следующих параметров: общая оценка состояния пациента, оценка боли, физическая функция и утренняя скованность, воспаление (при условии отсутствия ухудшения по другим признакам) [11,12] [13,14].…”

Section: первичные конечные точки для оценки эффективности терапииunclassified

“…Фармакодинамика. Фармакодинамические свойства лекарственного средства должны быть исследованы в соответствии с существующими рекомендациями 12 .…”

Section: дизайн исследованияunclassified

“…При выполнении поисковых КИ рекомендуется проведение плацебо-контролируемых параллельных исследований. Для оценки критериев эффективности терапии в краткосрочных исследованиях (12-24 недели) используются составные индексы ASAS 20 или 40 [12,13].…”

Section: терапевтические исследованияunclassified

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Planning a Clinical Trial Programme for Medicinal Products for the Treatment of Axial Spondyloarthritis

Горячев¹

2021

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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The criteria for diagnosis and classification of spondyloarthritides (SpAs) have undergone significant changes over the past 10 years. The emergence of new diagnostic methods and availability of new information on the prognosis of the disease outcome made it possible to distinguish a separate group of SpAs—axial SpA. Axial SpA is distinguished as a separate disease due to its high social significance, and special mechanisms of its development. The development of medicinal products for the treatment of axial SpA has some specific features, which requires preparation of specific recommendations for conducting clinical trials of such products. The aim of the study was to elaborate a methodological approach to clinical research and evaluation of efficacy and safety of medicinal products for systemic treatment of axial SpA. The study took into account the requirements/recommendations of the European Medicines Agency for planning clinical trials of medicinal products for the treatment of axial SpA, in order to streamline evaluation of national and foreign clinical trial results. The paper identifies the main stages of clinical trials, and proposes criteria for assessing product efficacy at each stage. It defines methods and tools for assessing clinical trial endpoints, which are necessary for evaluation of treatment effects. The paper describes specific aspects of clinical trial designs and their duration, and identifies the objectives of exploratory and confirmatory clinical trials. It also reviews treatment goals and treatment outcome evaluation. The study results could be used in elaboration of recommendations for clinical research of new medicinal products for axial SpA.

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Section: первичные конечные точки для оценки эффективности терапииunclassified

Section: дизайн исследованияunclassified

Section: терапевтические исследованияunclassified

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Planning a Clinical Trial Programme for Medicinal Products for the Treatment of Axial Spondyloarthritis

Горячев¹

2021

Vedomosti Nauchnogo tsentra ekspertizy sredstv meditsinskogo pr

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Early diagnosis of ankylosing spondylitis: assessment the criteria for axial spondyloarthritis, proposedby the International Working Group of the Assessment of SpondyloArthritis Society (ASAS)

Abstract: Low-dose prednisolone in addition to the initial disease-modifying antirheumatic drug in patient with early active rheumatoid arthritis reduces joint destruction and increases the remission rate: a 2-year randomized trial.

Cited by 1 publication

References 7 publications

Planning a Clinical Trial Programme for Medicinal Products for the Treatment of Axial Spondyloarthritis

Planning a Clinical Trial Programme for Medicinal Products for the Treatment of Axial Spondyloarthritis

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