Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- PD parameters
研究概览
简要总结
The main purposes of this study are to describe the pharmacodynamic effects, safety and pharmacokinetics of a single dose of sarilumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Patients with RA as defined by the 2010 revised American College of Rheumatology (ACR)
- •ACR Class I-III functional status, based on the 1991 revised criteria
- •Treated for a minimum of 12 weeks with Methotrexate with a stable dose of MTX for at least 8 weeks prior to screening visit
排除标准
- •Patients less than 18 years of age or minimum legal age
- •Prior treatment with any biologic anti-Interleukin 6 (IL-6) or IL-6 Receptor (IL-6R) antagonists
- •Use of parenteral corticosteroids or intra-articular corticosteroids within 4 weeks prior to screening
- •Use of oral corticosteroids in a dose higher than prednisone 10 mg or equivalent per day, or a change in dosage within 4 weeks prior to randomization
- •Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer
- •Treatment with oral/ biologic DMARDs (disease-modifying antirheumatic drugs), other than MTX, within a certain amount of time prior to screening visit
- •Active or suspected TB or at high risk of contracting TB
- •Fever, or chronic, persistent, or recurring infections requiring active treatment
- •HIV positive
- •Note: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.
研究组 & 干预措施
Sarilumab - dose 1
Single subcutaneous (SC) injection of Sarilumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
干预措施: Sarilumab (Drug)
Sarilumab - dose 2
Single SC injection of Sarilumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
干预措施: Sarilumab (Drug)
Tocilizumab - dose 1
Single intravenous (IV) administration of Tocilizumab, dose 1, plus methotrexate background treatment (dispensed and dosed according to local practice)
干预措施: Tocilizumab (Drug)
Tocilizumab - dose 2
Single IV administration of Tocilizumab, dose 2, plus methotrexate background treatment (dispensed and dosed according to local practice)
干预措施: Tocilizumab (Drug)
结局指标
主要结局
PD parameters
时间窗: baseline through week 4
Pharmacodynamic (PD) parameters, what a drug does to the body, will be collected from baseline through week 4: * the time to nadir (or peak) * change from baseline * area under the curve (AUC)
次要结局
- Percentage of TEAEs(baseline through week 6)
- PK parameters(baseline through week 4)