An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 132
- 试验地点
- 28
- 主要终点
- Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
研究概览
简要总结
Primary Objective:
To evaluate the immunogenicity of sarilumab administered as monotherapy.
Secondary Objectives:
- To evaluate the other safety aspects of sarilumab administered as monotherapy.
- To assess the exposure of sarilumab administered as monotherapy.
详细描述
Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 [REGN88]).
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
- 18 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 150 mg q2w
Sarilumab 150 mg subcutaneous (SC) injection every two weeks (q2w) for 24 weeks.
干预措施: sarilumab SAR153191 (REGN88) (Drug)
Sarilumab 200 mg q2w
Sarilumab 200 mg SC injection q2w for 24 weeks.
干预措施: sarilumab SAR153191 (REGN88) (Drug)
结局指标
主要结局
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
时间窗: From Baseline to Week 30 [End of study (EOS)]
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
次要结局
- Serum Sarilumab Concentration(Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30)