A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
研究概览
简要总结
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •score over 50 on the 0-100 VAS pain scale
- •acute, confirmed gout flare for no longer than 3 days
排除标准
- •Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
- •Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
- •Pregnant or breastfeeding women
- •Major surgery with high infection risk
- •History of severe allergy to food or drugs
- •History or risk of tuberculosis
- •Active infection
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Canakinumab
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
干预措施: canakinumab (Biological)
Canakinumab
Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.
干预措施: placebo matching dexamethasone (Other)
Dexamethasone
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
干预措施: dexamethasone (Drug)
Dexamethasone
Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.
干预措施: placebo matching canakinumab (Other)
结局指标
主要结局
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
时间窗: 72 hours
72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.
次要结局
- Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period(72 hours)
- Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period(4 months)
- Time to Walk Independently (if Applicable) During Treatment Period(4 months)
- Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study(4 months)
- Change in C-reactive Protein (CRP) From Baseline at Month 4(Baseline, Month 4)
- Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4(Baseline, Month 4)
- ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period(Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119)
- Change From Baseline in Pain Using a Visual Analog Scale at Month 4(Baseline, Month 4)
- Number of Patients Who Took Rescue Medication(4 months)