ACTRN12622001279718招募中4 期
Easing the way to achieving target serum urate in people with gout: a non-inferiority strategy trial using an allopurinol dosing model. (The Easy-Allo study)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 380
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Age over 18 years
- •2. Gout according to the 2015 ACR/EULAR criteria
- •3. Serum urate greater than or equal to 0.36mmol/l (6mg/dl) AND
- •-not taking allopurinol, but starting urate-lowering therapy strongly recommended in the 2020 ACR gout management guidelines (i.e. any of the following: greater than or equal to 2 gout flares/year, greater than or equal to 1 subcutaneous tophi, radiographic damage due to gout) OR
- •-already taking allopurinol for gout at lower than predicted dose OR
- •-already taking allopurinol but not regularly
- •4. Agreeable to starting or continuing allopurinol
- •5. Ability to give informed consent
- •6. Ability to communicate via telephone
排除标准
- •1. Severe kidney disease with estimated glomerular filtration rate (eGFR) <30ml/min/1.73m2
- •2. Contra-indication or previous intolerance to allopurinol
- •3. Concomitant azathioprine, due to interactions with allopurinol
- •4. HLA-B*5801 positive in high allele frequency populations (South East Asian and African), due to high risk of allopurinol hypersensitivity syndrome
- •5. Female of childbearing age not on contraception
- •5. Unstable co-morbid health conditions (e.g. NYHA stage 4 heart failure, recent myocardial infarction, advanced cancer)
- •6. Dementia
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