A Study to Determine the Presence and Volume of Monosodium Urate Crystals as Assessed by Dual-Energy Computed Tomography in Gout Patients Treated With Allopurinol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 223
- 主要终点
- Presence and volume of MSU crystal deposits as determined by DECT imaging
研究概览
简要总结
The purpose of this study is to determine presence and volume of monosodium urate (MSU) crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout subjects treated with allopurinol with and without visible tophi.
详细描述
DECT is a technique that enables visualization of MSU crystal deposits by analysis of the chemical composition of the scanned materials. This study will determine the extent of MSU crystal volume in the hands/wrists, feet/ankles, and knees as determined by DECT of subjects with gout taking a dose of at least 300 mg allopurinol daily for the past 12 weeks.
Patients with gout on allopurinol with and without tophi to be assessed using DECT imaging for crystal deposition with assessments, which include patient and provider assessments of disease severity and pain, prior to and after the scan.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
- •Subject is willing to adhere to the visit/protocol schedules.
- •Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
- •Subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12 weeks prior to Day 1, as the sole uratelowering therapy.
排除标准
- •Subject who is pregnant or breastfeeding.
- •Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements (including dual energy computed tomography imaging), or to complete the study.
- •Subject who has received an investigational therapy or has participated in any clinical trial or research study within 30 days of Day
- •Subject who has taken pegloticase (KRYSTEXXA®) or is expected to take pegloticase during the study.
结局指标
主要结局
Presence and volume of MSU crystal deposits as determined by DECT imaging
时间窗: 8 weeks
次要结局
- Joint erosion as visualized on DECT images(8 weeks)