A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 220
- 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 study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
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
- Triple (Participant, 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
- •Key Inclusion criteria:
- •Male or female participants aged 18 to 80 years;
- •Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
- •Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
- •A self-reported history of at least 2 gout flares in the year prior to screening.
排除标准
- •Key Exclusion criteria:
- •Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug;
- •Participants requiring dialysis;
- •Participants who had had an organ transplant;
- •Persistent chronic or active infections;
- •Previous exposure to rilonacept;
- •Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to 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 51.
干预措施: Placebo (Drug)
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 51.
干预措施: Allopurinol (Drug)
Rilonacept 80 mg
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
干预措施: Rilonacept (Drug)
Rilonacept 80 mg
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
干预措施: Allopurinol (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: Day 1 to Day 392 (Week 56)
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. 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 and including 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
- Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52)(Day 1 to Day 364 (Week 52))
- Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24)(Day 1 to Day 168 (Week 24))
- Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24)(Day 1 to Day 168 (Week 24))
- Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52)(Day 1 to Day 364 (Week 52))
- Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52)(Day 1 to Day 364 (Week 52))