NL-OMON52436招募中不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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
- •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
- •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
- •- 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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