A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,315
- 试验地点
- 124
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female 18 to 80 years of age;
- •Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- •Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
排除标准
- •Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- •Persistent chronic or active infections;
- •History of an allergic reaction to allopurinol;
- •History or presence of cancer within 5 years of the Screening Visit;;;
研究组 & 干预措施
Placebo
Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
干预措施: Placebo (Other)
Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
干预措施: Rilonacept (Biological)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline up to Week 20
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
次要结局
- Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))