Multicenter, Open Label Extension Study of 8 mg PEG-uricase in Subjects Who Completed Protocols C0405 or C0406 for Symptomatic Gout
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 22
- 主要终点
- Uric Acid (mg/dL)
研究概览
简要总结
This is an open-label extension phase of two double-blind, placebo-controled Phase 3 protocols evaluating PEG-uricase in the treatment of hyperuricemic subjects with symptomatic gout. The purpose of this study is to provide a continuation of treatment to subjects completing the double-blind studies and obtain long-term safety and efficacy data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed treatment in one of two double-blind, placebo controlled studies of PEG-uricase in subjects with hyperuricemia and symptomatic gout
排除标准
- •unstable angina
- •uncontrolled arrhythmia
- •uncontrolled hypertension
- •end stage renal disease requiring dialysis
研究组 & 干预措施
Placebo in RCT
Placebo arm in Randomized Controlled Trial (RCT), received pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in OLE
干预措施: pegloticase (Biological)
q4 RCT
Pegloticase every 4 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
干预措施: pegloticase (Biological)
q2 RCT
Pegloticase every 2 wk arm of Randomized Controlled Trial(RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extention (OLE) study
干预措施: pegloticase (Biological)
结局指标
主要结局
Uric Acid (mg/dL)
时间窗: Week 13, Week 25, Week 53, Week 101
Uric acid measured at 3 month-intervals
次要结局
- Gout Flare Incidence(Assessed in 3-month intervals up to 2 years)
- Tophus Response(Up to 2 years)
- Patient Reported Outcome: SF-36 Physical Component Summary Score(RCT Week 25; OLE Week 25; OLE Week 53, OLE Week 77, OLE Week 101)
- Gout Flare Frequency(Up to 2 years)