An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Percentage of patients with adverse events
研究概览
简要总结
Primary Objective:
To describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).
Secondary Objectives:
To describe the laboratory abnormalities (absolute neutrophil count [ANC], platelet counts, total cholesterol, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol, and liver function tests [LFTs]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.
To describe the pharmacokinetics (PK) of sarilumab and tocilizumab.
详细描述
Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sarilumab
Single subcutaneous (SC) dose of sarilumab
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Tocilizumab
Single SC dose of tocilizumab
干预措施: tocilizumab (Drug)
结局指标
主要结局
Percentage of patients with adverse events
时间窗: 6 weeks
Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)
时间窗: Baseline, Day 15
Percentage of patients with potentially clinically significant laboratory abnormalities
时间窗: 6 weeks
Change from baseline in laboratory parameters (hematology and biochemistry)
时间窗: Baseline, Day 15
次要结局
- Assessment of PK parameter: maximum concentration (Cmax)(Day 1 to Day 43)
- Change from baseline in laboratory parameters (hematology and biochemistry)(Baseline, Day 29 and Day 43)
- Assessment of PK parameter: time to Cmax (tmax)(Day 1 to Day 43)
- Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)(Day 1 to Day 43)
- Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)(Baseline, Day 29 and Day 43)