ABSTRACT

Introduction: One of the reasons for failures of disease-modifying osteoarthritis drug clinical trials has been the radiography-based definition of structural eligibility criteria. Imaging, particularly MRI, has a critical role in planning and conducting clinical trials of osteoarthritis.

Areas covered: A literature search was performed using keywords including ‘osteoarthritis,’ ‘knee,’ ‘MRI,’ ‘intra-articular injection,’ ‘semiquantitative scoring,’ ‘clinical trial,’ and other specific terms where relevant. The core concepts of using MRI in osteoarthritis clinical trials are explained focusing on knee osteoarthritis, including its role in determining patient eligibility and inclusion/exclusion criteria as well as outcome measures from the expert musculoskeletal radiologist’s perspective. A brief overview of statistical analyses that should be deployed in clinical trials utilizing semiquantitative MRI analyses is discussed.

Expert opinion: In order to increase chances to detect measurable efficacy effects, investigators should consider utilizing MRI from screening to outcome assessment. Recognition of several phenotypes of osteoarthritis helps in participant stratification and will lead to more targeted clinical trials. Inclusion and exclusion criteria need to be defined using not only radiography but also MRI. Correct intra-articular injection of investigational compounds is critically important if intra-articular drug delivery is required, and such procedure should be performed and documented using appropriate imaging guidance.

摘要

简介： 改善疾病的骨关节炎药物临床试验失败的原因之一是基于射线照相的结构合格标准定义。成像，尤其是 MRI，在规划和进行骨关节炎临床试验方面发挥着关键作用。

涵盖的领域：使用关键字进行文献检索，包括“骨关节炎”、“膝关节”、“MRI”、“关节内注射”、“半定量评分”、“临床试验”和其他相关的特定术语。解释了在骨关节炎临床试验中使用 MRI 的核心概念，重点关注膝骨关节炎，包括其在确定患者资格和纳入/排除标准中的作用，以及从专家肌肉骨骼放射科医师的角度测量结果。讨论了应在临床试验中使用半定量 MRI 分析的统计分析的简要概述。

专家意见：为了增加检测可测量疗效影响的机会，研究人员应考虑从筛查到结果评估利用 MRI。识别骨关节炎的几种表型有助于参与者分层，并将导致更有针对性的临床试验。纳入和排除标准不仅需要使用放射线照相术，还需要使用 MRI 来定义。如果需要关节内给药，正确的关节内注射研究化合物至关重要，并且应该使用适当的成像指导执行和记录此类程序。