NCT05312268招募中4 期
Efficacy and Safety of Rasburicase in the Treatment of Chronic Gouty Arthritis: A Multicenter Randomized Controlled Study
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Monosodium urate crystal volume change evaluated by dual energy CT
研究概览
简要总结
The study will establish efficacy and safety of rasburicase in chronic gouty arthritis
详细描述
The study hypothesis is that the proportion of patients who achieved the primary endpoint after 12 weeks of treatment with rasburicase combined with oral urate-lowering therapy is superior to 12 weeks of treatment with oral urate-lowering therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained before any assessment is performed, able to understand and comply with the requirements of the study;
- •Male and female patients 18 to 70 years of age;
- •Fulfill the ACR/EULAR 2015 gout classification criteria;
- •Tophi detected by physical examination;
- •Serum urate>300μmol/L (5mg/dl) after one-month maximum dose of urate-lowering therapy (allopurinol 600mg/d or febuxostat 80mg/d in combination with benzbromarone 100mg/d) unless intolerable OR no reduction in size of tophi after serum urate<300μmol/L (5mg/dl) for six month;
排除标准
- •Pregnant women, lactating women, and men or women who have recently prepared for pregnancy;
- •Abnormal liver function with AST, ALT, and GGT >3 times ULN;
- •Blood WBC<4.0×10^9/L, and/or hemoglobin <90g/L, and/or platelets;<100×10^9/L; or other hematologic disorders;
- •eGFR<15 ml/min;
- •Receive following medications: azathioprine, mercaptopurine, cyclosporine, pyrazinamide, ethambutol and sulfamethoxazole
- •Psychiatric disorders, history of alcoholism, drug or other substance abuse
- •Immunodeficiency diseases, uncontrolled infection, etc;
- •Sericosis, glucose-6-phosphate dehydrogenase activity deficiency
- •Allergy to biological agents and chronic active urticaria.
研究组 & 干预措施
Group A
Other
Rasburicase treatment at week 1, 4 and 8 with stable dose oral urate-lowering therapy for 24 weeks.
干预措施: Rasburicase (Drug)
Group B
Other
Rasburicase treatment at week 12, 16 and 20 with stable dose oral urate-lowering therapy for 24 weeks.
干预措施: Rasburicase (Drug)
结局指标
主要结局
Monosodium urate crystal volume change evaluated by dual energy CT
时间窗: Baseline to week 12 and week 12 to week 24
Dual energy CT at baseline, week 12 and week 24
次要结局
- The percentage of patients who have at least one tophi disappeared(Baseline to week 12 and week 12 to week 24)
- The percentage of patients who had achieved serum urate concentrations less than 300 μmol/L (5mg/dl) after 3 months of rasburicase treatment(Baseline to week 12 and week 12 to week 24)
- Tophus volume change evaluated by physical examination(Baseline to week 12 and week 12 to week 24)
- Change of Tophus Impact Questionnaire (TIQ)-20 score(Baseline to week 12 and week 12 to week 24)
- Severe adverse event(Baseline to week 12 and week 12 to week 24)
- Number of gout flare(Baseline to week 12 and week 12 to week 24)
- Change of patient global assessment(Baseline to week 12 and week 12 to week 24)
- Change of physician global assessment(Baseline to week 12 and week 12 to week 24)
- Change of Visual Analog Scale (VAS) for Pain in gout flare(Baseline to week 12 and week 12 to week 24)
- Change of global functional status(Baseline to week 12 and week 12 to week 24)
- Change of Short Form 12 health survey score(Baseline to week 12 and week 12 to week 24)
- Adverse event(Baseline to week 12 and week 12 to week 24)
- Number of patients who have positive anti-rasburicase antibodies(Baseline to week 12 and week 12 to week 24)
研究者
研究点 (4)
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