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临床试验/CTIS2024-511111-13-01
CTIS2024-511111-13-01进行中(未招募)1 期

GOut TrEatment STrategy (GO TEST) FINALE study, a multicentre pragmatic randomized superiority trial of continuation versus cessation of urate lowering therapies in gout in remission.

Sint Maartenskliniek0 个研究点目标入组 310 人开始时间: 2024年6月28日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
310

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

年龄范围
18 至 64(—)
性别
All

入选标准

  • Patients with clinical diagnosis of gout and/or fulfilling the 2015 ACR-EULAR gout criteria, - Use of ULT (allopurinol, benzbromarone and/or febuxostat), Achieved remission for = 12 months based on adapted preliminary gout remission criteria (29). o Free of flares and/or clinically apparent tophi during the last 12 months o Serum urate =0.36 mmol/l at baseline and all values in the last 12 months should not be >0.36 mmol/l o Pain due to gout <2 using a 10-point Likert-type scale at baseline o Patient global assessment of gout disease activity <2 using a 10-point Likert-type scale at baseline, Age =18 years and mentally competent, Signed written informed consent

排除标准

  • - Not being able to speak, read or write Dutch well enough, No ability to measure the outcome of the study in the participant (e.g. life expectancy <2 years, planned relocation out of reach of study center), A strong contra-indication for glucocorticoids, NSAIDs AND colchicine, as this hampers flare treatment, Use of ULT (also) for any other indication than gout (for example nephrolithiasis), Currently taking regular glucocorticoids, and/or colchicine, and/or interleukine-1 inhibitors for any diagnosis and/or the use of regular NSAID intake for gout activity, A history of myocardial infarction or stroke in the past six months and/or congestive heart failure NYHA class III or IV

研究者

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