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. - GO TEST FINALE

Sint Maartenskliniek0 个研究点目标入组 310 人开始时间: 2021年1月11日最近更新: 2021年4月5日

试验速览

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•To be eligible to participate in this study, a participant must meet all of the following criteria:
•- 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
•oFree of flares and/or clinically apparent tophi during the last 12 months
•oSerum urate =0.36 mmol/l at baseline and all values in the last 12 months should not be >0.36 mmol/l
•oPain due to gout <2 using a 10-point Likert-type scale at baseline
•oPatient 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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•A potential participant will be excluded from participation in this study if one of the following criteria has been met:
•-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

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