NCT01593527撤回3 期
A Randomized Double-blind Active-controlled Trial of Canakinumab Versus Triamcinolone Acetonide on Reducing the Proportion of Patients With Any New Gouty Arthritis Flare(s) in Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
研究概览
简要总结
The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Experimental
Canakinumab 150 mg s.c.
干预措施: ACZ885 (Drug)
Arm 2
Experimental
Triamcinelone acetonide 40 mg i.m.
干预措施: Triamcinelone acetonide (Drug)
结局指标
主要结局
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing
时间窗: 12 Weeks
次要结局
- Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution(12 weeks)
- Number of patients needing rescue medication use during acute gouty arthritis flare(s)(12 Weeks)
- Measurement of efficacy using inflammatory markers(12 Weeks)
- Time to 50% reduction of baseline pain intensity in the most affected joint(12 weeks)
- The time to the first new gout flare(12 Weeks)
研究者
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