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Published in: Trials 1/2020

01-12-2020 | Knee Osteoarthritis | Study protocol

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

Authors: Zhaohua Zhu, Qinghong Yu, Xiaomei Leng, Weiyu Han, Zhanguo Li, Cibo Huang, Jieruo Gu, Yi Zhao, Kang Wang, Tianwang Li, Yifang Mei, Jianhua Xu, Zhiyi Zhang, David Hunter, Flavia Cicuttini, Xiaofeng Zeng, Changhai Ding

Published in: Trials | Issue 1/2020

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Abstract

Background

Osteoarthritis (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/design

This 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.

Discussion

If 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 registration

ClinicalTrials.gov NCT03815448. Registered on 21 January 2019.
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Metadata
Title
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
Authors
Zhaohua Zhu
Qinghong Yu
Xiaomei Leng
Weiyu Han
Zhanguo Li
Cibo Huang
Jieruo Gu
Yi Zhao
Kang Wang
Tianwang Li
Yifang Mei
Jianhua Xu
Zhiyi Zhang
David Hunter
Flavia Cicuttini
Xiaofeng Zeng
Changhai Ding
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04687-3

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