A Phase 3, Multicenter, Double-blind, Randomized Controlled Study Evaluating the Efficacy and Safety of Pegloticase Administered by Subcutaneous Injection Compared With Pegloticase Administered by Intravenous Injection, Both Administered Concurrently With Methotrexate Weekly, in Participants With Uncontrolled Gout
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Amgen
- 入组人数
- 270
- 试验地点
- 72
- 主要终点
- Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
研究概览
简要总结
The primary objective of this trial is to evaluate the effect of pegloticase 18 mg subcutaneously (SC) every two weeks with methotrexate (MTX) versus pegloticase 8 mg intravenously (IV) every two weeks with MTX on the response rate during Month 6, as measured by the sustained normalization of serum uric acid (sUA) to < 6 mg/dL for at least 80% of the time during Month 6.
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
- Double (Participant, Investigator)
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
- •Participant has provided informed consent before initiation of any trial-specific activities/procedures.
- •Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
- •Participants willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.
- •Participants with uncontrolled gout, as meeting the protocol defined criteria.
排除标准
- •Glucose-6-phosphate dehydrogenase deficiency (tested at the screening visit).
- •Liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) > 1.25 x upper limit of normal (ULN) or albumin < the lower limit of normal (LLN) at the screening visit.
- •Uncontrolled diabetes mellitus and/or hemoglobin A1c (HbA1c) > 8%.
- •Known intolerance to MTX.
- •Participant received prior treatment with pegloticase, another recombinant uricase (ie, rasburicase or pegadricase), or concomitant therapy with a polyethylene glycol (PEG)-conjugated drug.
- •A known intolerance to all protocol standard gout flare prophylaxis regimens (ie, participant must be able to tolerate at least 1 of the following: colchicine and/or non-steroidal anti-inflammatory drug and/or low-dose prednisone ≤ 10 mg/day or equivalent dose of other corticosteroid).
- •Chronic renal impairment defined as estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) calculations < 40 mL/min/1.73 m^2 or currently on dialysis.
研究组 & 干预措施
Pegloticase SC with MTX
Participants will receive pegloticase SC every two weeks with MTX.
干预措施: Pegloticase (Drug)
Pegloticase SC with MTX
Participants will receive pegloticase SC every two weeks with MTX.
干预措施: Methotrexate (Drug)
Pegloticase IV with MTX
Participants will receive pegloticase IV every two weeks with MTX.
干预措施: Methotrexate (Drug)
Pegloticase IV with MTX
Participants will receive pegloticase IV every two weeks with MTX.
干预措施: Pegloticase (Drug)
结局指标
主要结局
Number of Participants Achieving Month 6 Response at Weeks 20, 21, 22, 23, and 24
时间窗: Month 6 (Weeks 20, 21, 22, 23, and 24)
Defined as Achieving and Maintaining sUA \< 6 mg/dL for at Least 80% of the Time During Month 6.
次要结局
- Number of Participants With Serious Injection Site Reactions Through Week 48(Up to Week 48)
- Number of Participants With Serious Adjudicated Infusion Reactions (Including Adjudicated Anaphylaxis) Through Week 48(Up to Week 48)
- Number of Participants With Adjudicated Anaphylaxis Through Week 48(Up to Week 48)
- Serum Concentrations of Pegloticase Following SC and IV Administration(Up to Week 48)