NCT01026519已完成1 期
A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- hs-C reactive protein (hs-CRP)
研究概览
简要总结
This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years of age
- •Subjects must weigh >50 and <100 kg
- •Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III
排除标准
- •A history of Listeriosis or active tuberculosis (TB)
- •Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
- •History of prior articular or prosthetic joint infection
- •History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
- •Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study
研究组 & 干预措施
Dose 1
Experimental
Active dose
干预措施: REGN88 (Drug)
Dose 2
Experimental
Active dose
干预措施: REGN88 (Drug)
Dose 3
Experimental
Active 3
干预措施: REGN88 (Drug)
Dose 4
Placebo Comparator
Placebo dose
干预措施: Placebo (Other)
结局指标
主要结局
hs-C reactive protein (hs-CRP)
时间窗: 43 Days
次要结局
- Subject's Assessment of Pain and Subject's Global Assessment of Disease activity(43 Days)
研究者
研究点 (1)
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