Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial

Trials

Weiyu Han¹  Zhaohua Zhu²  Changhai Ding³  David Hunter⁴  Flavia Cicuttini⁵  Yi Zhao⁶  Zhanguo Li⁷  Qinghong Yu⁸  Tianwang Li⁹  Jieruo Gu^1,10  Cibo Huang^1,11  Xiaomei Leng^1,12  Xiaofeng Zeng^1,12  Jianhua Xu^1,13  Kang Wang^1,13  Yifang Mei^1,14  Zhiyi Zhang^1,14 

[1] Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China;Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia;Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China;Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia;Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia;Clinical Research Centre, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China;Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia;Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia;Department of Rheumatology & Allergy, Xuanwu Hospital, Capital Medical University, Beijing, China;Department of Rheumatology & Immunology, Peking University People’s Hospital, Beijing, China;Department of Rheumatology and Clinical Immunology, Zhujiang Hospital of Southern Medical University, Guangzhou, China;Department of Rheumatology and Immunology, Guangdong Second Provincial General Hospital, Guangzhou, China;Department of Rheumatology, 3rd Affiliated Hospital of Sun Yet-Sen University Guangzhou, Guangzhou, Guangdong, China;Department of Rheumatology, Beijing Hospital, National Center of Gerontology, Beijing, China;Department of Rheumatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China;Department of Rheumatology, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China;Department of Rheumatology, the First Affiliated Hospital of Harbin Medical University, Harbin, China;

关键词: Methotrexate;    Osteoarthritis;    Effusion-synovitis;    Pain;   

DOI  :  10.1186/s13063-020-04687-3

来源: Springer

【 摘 要 】

BackgroundOsteoarthritis (OA) is a common chronic disease in older adults. Currently, there are no effective therapies to reduce disease severity and progression of knee OA (KOA), particularly in mid- to late-stages. This study aims to examine the effect of methotrexate (MTX) on knee effusion-synovitis and pain in symptomatic patients with mid- to late-stage KOA.Methods/designThis protocol describes a multicentre randomised placebo-controlled clinical trial aiming to recruit 200 participants with mid- to late-stage symptomatic KOA and with effusion-synovitis grade of ≥ 2. Participants will be randomly allocated to the MTX group (start from 5 mg per week for the first 2 weeks and increase to 10 mg per week for the second 2 weeks and 15 mg per week for the remaining period if tolerated) or the placebo group. Primary outcomes are effusion-synovitis size measured by magnetic resonance imaging (MRI) and knee pain assessed by visual analogue scale (VAS). Secondary outcomes are signal intensity alteration within infrapatellar fat pad (IPFP) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score and subscores, and the Outcome Measures in Rheumatology Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responders. Both intention-to-treat and per-protocol analyses will be performed.DiscussionIf MTX intervention can relieve symptoms and reduce inflammation in patients with mid- to late-stage KOA, it has the potential for significant clinical and public health impact as this low-cost and commonly used intervention would delay the time to knee replacement, leading to substantial cost savings and improve quality of life.Trial registrationClinicalTrials.gov NCT03815448. Registered on 21 January 2019.

【 授权许可】

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