Heijman Michelle W J, van den Ende Cornelia H M, Cornel Jan H, Smolders José M H, Schers Henk J, Kievit Wietske, Koeter Sander, van den Bemt Bart J F, Popa Calin D
Department of Research, Sint Maartenskliniek, Nijmegen, Netherlands
Department of Rheumatology, Radboud University Medical Center, Nijmegen, Netherlands.
BMJ Open. 2025 Apr 14;15(4):e098096. doi: 10.1136/bmjopen-2024-098096.
Osteoarthritis (OA) is a multifactorial disease in which low-grade inflammation is considered to play a pivotal role. Although colchicine is a widely used anti-inflammatory drug in the treatment of gout, its effect in OA is still disputed due to inconsistent results of short-term clinical trials. Therefore, we aim to evaluate the effect of long-term colchicine 0.5 mg once daily on the incidence of knee or hip replacements in patients with knee or hip OA.
The ECHO trial is a prospective, multicentre, randomised, double-blind, placebo-controlled, phase III trial in which 1200 participants with knee or hip OA tolerant to colchicine during a 30-day run-in period will be 1:1 randomised to colchicine 0.5 mg once daily or matching placebo using concealed allocation. The primary endpoint is the time from randomisation to the first knee or hip replacement assessed up to 4.5 years. Secondary endpoints include course of pain, physical function, joint space narrowing, low-grade inflammation, quality of life, clinical or radiological onset of OA in a new joint group other than present at baseline, number of participants using pain medication during the study, onset of new cardiovascular events (ie, myocardial infarction, ischaemia-driven coronary revascularisation, ischaemic stroke, peripheral artery disease or cardiovascular death) and direct and indirect costs related to treatment and disease burden due to OA. Harm-related endpoints include the number of (serious) adverse events, the number of withdrawals due to (serious) adverse events and changes in laboratory data (ie, serum creatinine, estimated glomerular filtration rate and alanine transferase) throughout the study. The primary analysis will be performed according to the intention-to-treat principle.
This trial has been approved by the Medical Ethics Review Committee East-Netherlands. Findings will be presented at scientific meetings and published in a peer-reviewed scientific journal.
NCT06578182.
骨关节炎（OA）是一种多因素疾病，其中低度炎症被认为起关键作用。尽管秋水仙碱是治疗痛风广泛使用的抗炎药物，但由于短期临床试验结果不一致，其在OA中的作用仍存在争议。因此，我们旨在评估每日一次0.5毫克秋水仙碱长期治疗对膝或髋OA患者膝或髋关节置换发生率的影响。
ECHO试验是一项前瞻性、多中心、随机、双盲、安慰剂对照的III期试验，在30天导入期对秋水仙碱耐受的1200名膝或髋OA患者将按1:1随机分为每日一次0.5毫克秋水仙碱组或匹配安慰剂组，采用隐蔽分配。主要终点是从随机分组到首次膝或髋关节置换的时间，评估长达4.5年。次要终点包括疼痛病程、身体功能、关节间隙变窄、低度炎症、生活质量、除基线时存在的关节外新关节组中OA的临床或放射学发病、研究期间使用止痛药物的参与者数量、新心血管事件（即心肌梗死、缺血驱动的冠状动脉血运重建、缺血性中风、外周动脉疾病或心血管死亡）的发病以及与OA治疗和疾病负担相关的直接和间接成本。与危害相关的终点包括（严重）不良事件数量、因（严重）不良事件导致的撤药数量以及整个研究过程中实验室数据（即血清肌酐、估计肾小球滤过率和丙氨酸转氨酶）的变化。主要分析将根据意向性治疗原则进行。
本试验已获得荷兰东部医学伦理审查委员会批准。研究结果将在科学会议上公布，并发表在同行评审的科学期刊上。
NCT06578182。
