A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 & CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 and placebo matching to triamcinolone acetonide
ACZ885H
干预措施: Canakinumab, ACZ885 (Drug)
Triamcinolone acetonide 40 mg
ACZ885H
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
时间窗: at 72 hours post-dose
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
时间窗: 12 weeks
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
次要结局
- Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment(baseline through week 12)
- The Number of Patients With at Least 1 New Gout Flare(12 weeks)
- Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment(baseline through 12 weeks)
- Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment(baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose)
- Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment(12 weeks)
- Time to First Rescue Medication Intake(12 weeks)
- Percent Patients Who Took Rescue Medication(12 weeks)
- Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.(12 weeks)
- High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose(72 hours post dose)
- Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment(baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose)
- Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.(72 hours through week 12)
- Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment(baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose)
- Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment(baseline through week 12)
- Time to Complete Resolution of Pain: Survival Analysis by Treatment(12 weeks)