NCT01431638已完成3 期
A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- Number of Participants Who Reported Adverse Events
研究概览
简要总结
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Canakinumab 150mg
Experimental
Canakinumab 150mg in prefilled syringe subcutaneously
干预措施: Canakinumab 150mg in prefilled syringe (Drug)
结局指标
主要结局
Number of Participants Who Reported Adverse Events
时间窗: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
次要结局
- Probability of New Gout Flares at End of Study(Up to Day 337)
- Number of Participant With New Flares(up to 36 weeks)
- Change From Baseline in Pain Intensity on a 5-point Likert Scale(Baseline, upto 14 days post-dose)
- Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time(Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose)
- Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint(Baseline, 7 days post-dose)
- Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment(48 weeks post-dose)
- Number of Participants Responded for Physician's Global Assessment of Response to Treatment(7 days post-dose)
研究者
研究点 (1)
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