A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability of a single dose of subcutaneously administered sarilumab in Japanese patients with rheumatoid arthritis (RA) who are receiving concomitant treatment with methotrexate.
Secondary Objective:
To assess the pharmacokinetic profile of a single subcutaneous (SC) dose of sarilumab in Japanese RA patients.
详细描述
Total study duration per patient is up to 88 days
- Screening: 3 to 28 days
- Treatment: 1 day
- Follow-up: 57± 3 days after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（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 (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: methotrexate (Drug)
Sarilumab (SAR153191, REGN88) Dose 1
First dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: folic acid (Drug)
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: methotrexate (Drug)
Sarilumab (SAR153191, REGN88) Dose 2
Second dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: folic acid (Drug)
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: methotrexate (Drug)
Sarilumab (SAR153191, REGN88) Dose 3
Third dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: folic acid (Drug)
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: methotrexate (Drug)
Sarilumab (SAR153191, REGN88) Dose 4
Fourth dose of Sarilumab in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: folic acid (Drug)
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: placebo (Drug)
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: methotrexate (Drug)
Placebo Dose 5
Placebo to match Sarilumab (SAR153191, REGN88) in a single SC injection. Methotrexate (stable dose) and folic acid are continued as background therapy
干预措施: folic acid (Drug)
结局指标
主要结局
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG)
时间窗: Up to 88 days or end-of-study (EoS)
Assessment of the occurrence of anti-sarilumab antibodies
时间窗: Day 1, Day 15, Day 29, Day 57
Assessment of the titer of anti-sarilumab antibodies
时间窗: Day 1, Day 15, Day 29, Day 57
次要结局
- Assessment of PK parameter - maximum concentration (Cmax)(At each visit, up to 88 days)
- Assessment of PK parameter - area under curve (AUC)(At each visit, up to 88 days)
- Assessment of PK parameter - time to maximum concentration (tmax)(At each visit, up to 88 days)