Evolution of Tophus and Erosions of Hands and Feet With Urate-lowering Therapy: Prospective Study Using Dual-Energy Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- the percentage of decrease in crystal volume of the target tophus
研究概览
简要总结
The main objective is to evaluate the decrease in crystalline volume of the target tophus using Dual-Energy Computed Tomography (DECT), after 6 months +/- 1 month of urate-lowering therapy with target uricemia.
Study hypothesis
- The dynamics of tophus resolution with urate-lowering therapy is poorly understood.
- It is variable according to the location of the tophus, peri articular / intratendinous, but also probably at the feet / hands, the initial overall volume of the tophus, the initial crystal charge of the tophus. Knowledge of prognostic factors for tophus resolution will help determine the best target for treatment follow-up for each patient.
- Erosions are the consequence of tophus. Tophus resolution could be associated with repair of erosions and stabilization of joint destruction.
详细描述
Study design The research is a non-randomized prospective bi-centric study in adult patients with tophaceous gout. It aims at studying tophus resolution (main objective), and prognostic factors for tophus resolution (secondary objective), and bone erosions, with Dual-Energy Computed Tomography (DECT) (secondary objective).
Study population
- Adult patients with a tophaceous gout but no urate-lowering treatment or treatment but target not reached (target = uricemia < 360µmol/L).
- Recruitment of patients during a visit or hospitalization in rheumatology at Lariboisière Hospital.
Calculated size of study population: 50 patients
No control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Patient with a tophaceous gout
- •Without urate-lowering treatment or with treatment but uricemia not at target
- •Having given its free and informed consent to participate in this study
- •Affiliated with a social security system
排除标准
- •Pregnant or breastfeeding woman
- •Participation in another intervention research or period of exclusion due to a previous research.
- •Impossibility to position oneself in ventral position (position for hands/wrists DECT acquisition).
结局指标
主要结局
the percentage of decrease in crystal volume of the target tophus
时间窗: after 6 months +/- 1 month of traitment
decrease in crystal volume of the target tophus detected using dual-energy CT compared to the volume at baseline
次要结局
未报告次要终点