MERINO研究方案：一项随机安慰剂对照试验，评估甲氨蝶呤对糜烂性手骨关节炎患者的疗效、安全性和成本效益。

Osteoarthritis and cartilage open Pub Date : 2024-12-15 DOI:10.1016/j.ocarto.2024.100558

Alexander Mathiessen , Line Gaundal , Joseph Sexton , Dag Sjølie , Pernille Steen Pettersen , Barbara Slatkowsky-Christensen , Ida Kristin Haugen

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摘要

目的：以往关于甲氨蝶呤治疗手骨关节炎（OA）疗效的研究显示了相互矛盾的结果。MERINO试验旨在研究甲氨蝶呤治疗疼痛性炎症性糜烂性手性关节炎的疗效和安全性。设计：将从风湿病门诊招募163名患有糜烂性手部OA、超声检查的滑膜炎、视觉模拟评分（VAS） 40-80 mm手指关节疼痛的参与者。参与者以1:1的比例随机接受胶囊口服甲氨蝶呤20mg /周或安慰剂，双盲治疗12个月。主要终点是6个月时VAS手指关节疼痛。主要的次要结果是6个月时澳大利亚/加拿大手指数（AUSCAN）的手功能和12个月时Verbruggen-Veys解剖阶段评分系统的放射学进展。其他次要终点包括手部僵硬、疾病活动度、健康相关生活质量、握力、临床关节计数、超声和MRI检查的滑膜炎、MRI检查的骨髓病变、成本效益以及膝盖和臀部的症状。不良事件将被记录。主要分析将在完整的分析集上进行。结论：该试验的结果将对糜烂性手性骨关节炎患者具有临床相关性，并可能影响未来的治疗建议。临床试验注册：EU CT号：2023-510523-30-00，NCT04579848。

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Protocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis

Objective

Previous studies on the efficacy of methotrexate in people with hand osteoarthritis (OA) have shown conflicting results. The MERINO trial aims to investigate the efficacy and safety of methotrexate in people with painful inflammatory erosive hand OA.

Design

In total 163 participants with erosive hand OA, synovitis by ultrasound, and finger joint pain of 40–80 mm on a visual analogue scale (VAS) will be recruited from a rheumatology outpatient clinic. Participants are randomized 1:1 to receive either encapsulated oral methotrexate 20 mg/week or placebo for 12 months in a double-blind manner. The primary endpoint is VAS finger joint pain at 6 months. Key secondary outcomes are hand function by the Australian/Canadian hand index (AUSCAN) at 6 months and radiographic progression by the Verbruggen-Veys anatomical phase scoring system at 12 months. Other secondary endpoints include hand stiffness, disease activity, health-related quality of life, grip strength, clinical joint counts, synovitis by ultrasound and MRI, bone marrow lesions by MRI, cost-effectiveness, and symptoms in knees and hips. Adverse events will be recorded. The primary analysis will be performed on full analysis set.