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New considerations in the design of clinical trials for spondyloarthritis

机译：脊椎关节炎临床试验设计的新考虑

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Inflammation in spondyloarthritis (SpA) primarily affects the axial skeleton including the sacroiliac joints, the spine and the peripheral joints. Currently, axial and peripheral SpA can be distinguished, and new criteria have been developed to classify these subtypes. Ankylosing spondylitis (AS; Bechterew's disease) belongs to the spectrum of axial SpA. To date, randomized clinical trials in this field have usually been conducted in patients with AS, showing efficacy of non-steroidal anti-inflammatory drugs and of TNF-a-inhibiting biologicals on signs and symptoms of AS, on acute phase reactants and on inflammation on MRI of the spine and sacroiliac joints. In this article, classic trial design in AS is discussed, as well as the implications of the development of the new Assessment in Spondyloarthritis international Society criteria and new outcome measures in the field of SpA on future trial designs with regard to new drug development.
机译：脊柱关节炎（SpA）中的炎症主要影响包括skeleton关节，脊柱和周围关节的轴向骨骼。目前，可以区分轴向和周围SpA，并且已经开发出新的标准来对这些亚型进行分类。强直性脊柱炎（AS; Bechterew病）属于轴向SpA谱。迄今为止，通常在AS患者中进行该领域的随机临床试验，显示非甾体类抗炎药和抑制TNF-α的生物制剂对AS的体征和症状，急性期反应物和炎症的功效。 sa关节和关节的MRI检查在本文中，将讨论AS中的经典试验设计，以及国际脊柱关节炎国际评估标准的制定以及SpA领域中新成果指标对新药开发的未来试验设计的影响。

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