A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 34
- 主要终点
- Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
研究概览
简要总结
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female greater than 18 years of age;
- •Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout;
- •At least 2 gout flares in the year prior to the screening visit.
排除标准
- •Acute gout flare within 2 weeks of the screening visit and during screening;
- •Persistent chronic or active infections;
- •History of an allergic reaction to allopurinol;
- •History or presence of cancer within 5 years of the screening visit.
结局指标
主要结局
Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12)
时间窗: Day 1 (Baseline) to Day 84 (Week 12)
A gout flare was defined as participant reported acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure. For drop-outs, only flares occurred before Day 84 were counted, regardless whether the flares occurred during the treatment period or not.
次要结局
- Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))
- Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))
- Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))
- Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))
- Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))
- Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12)(Day 1 (Baseline) to Day 84 (Week 12))