Combination Treatment Study in Subjects with Tophaceous Gout
痛风石痛风受试者联合治疗研究
Phase 3 Randomized, Double-Blind, Multicenter, Placebo-Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects with Tophaceous Gout
一项旨在评估雷西那德与非布索坦较非布索坦单一用药在降低痛风石痛风受试者血清尿酸和消散痛风石方面的疗效与安全性的3期随机、双盲、多中心、安慰剂对照联合研究
Primary Objective:
主要目的：
To determine the efficacy of lesinurad by Month 6 when used in combination with febuxostat compared to febuxostat monotherapy
当雷西那德与非布索坦联合使用至第6个月时，对比非布索坦单药治疗，以确定雷西那德的疗效。
Secondary Objectives:
次要目的：
To determine the efficacy of lesinurad by Month 12 when used in combination with febuxostat compared to febuxostat monotherapy
当雷西那德与非布索坦联合使用至第12个月时，对比非布索坦单药治疗，确定雷西那德的疗效。
To determine the safety of lesinurad over 6 months and 12 months when used in combination with febuxostat
当雷西那德与非布索坦联合使用超过6个月与12个月时，确定雷西那德的安全性。
To investigate by a population analysis approach the influence of intrinsic factors (age, sex, race, body weight, renal function, concomitant medication use) on oral clearance of lesinurad
通过人群分析法研究受试者内在因素(年龄、性别、种族、体重、肾功能与合并用药)对雷西那德口服清除率的影响。
To determine the effect of lesinurad when used in combination with febuxostat on Health Related Quality of Life and physical function.
在雷西那德与非布索坦联合使用时，确定雷西那德对受试者健康相关生存质量和生理机能的影响。
Test Product; Dose; and Mode of Administration:
测试产品；剂量和给药方式：
Lesinurad 200 mg or 400 mg tablets will be supplied to all randomized subjects. Febuxostat 80 mg tablets will be supplied to all qualified subjects beginning approximately 21 days before the Day 1 (Baseline) Visit.
所有随机受试者将服用雷西那德200毫克或400毫克片剂。所有符合标准的受试者在首日（基线）访视前约21天，开始服用非布索坦80毫克片剂。
All doses of lesinurad should be taken in the morning with food and one cup of water.
所有剂量的雷西那德应在早晨与食物一起，同时就着整杯水吞服。
The dose and dosing regimen of febuxostat should not be changed during the course of this study except for safety reasons. It is recommended that the morning dose of febuxostat be taken at the same time as lesinurad is taken.
除安全原因外，在本研究的过程中，不应改变非布索坦的剂量与给药方案。建议受试者在服用雷西那德的同时，服下非布索坦的早晨剂量。
Efficacy Assessments:
疗效评估：
Endpoints
终点
Primary:
主要：
• Proportion of subjects with an sUA level that is < 5.0 mg/dL by Month 6
至第6个月时，血清尿酸水平<5.0毫克/分升的受试者比例。
• Key secondary endpoints include:
关键次要终点包含：
Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12
至第12个月时，经历了至少有1个目标痛风石完全消散的受试者比例。
Proportion of subjects with a best tophus response on at least 1 target tophus of complete or partial resolution by Month 12
至第12个月时，具备至少有1个目标痛风石完全或部分消散的最佳痛风石反应的受试者比例。
Proportion of subjects with an improvement from Baseline in HAQ-DI of at least 0.25 at Month 12
在第12个月时，健康评估问卷残疾指数基线改善至少0.25的受试者比例。
Safety Assessments:
安全性评估：
Safety assessments will include adverse events (AEs), previous and concomitant therapies, medical and surgical history, laboratory data except sUA results, urinalysis data, compliance with study medications, physical exam, ECG, and vital signs.
安全性评估将包括不良事件(AEs)、既往和合并治疗、医疗和手术史、除血清尿酸结果之外的实验室数据、尿液分析数据、研究药物的依从性、体检、心电图和生命体征。
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