NCT00902369已完成2 期
A Study of AK106-001616 in Patients With Rheumatoid Arthritis (RA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
研究概览
简要总结
This will be a Phase II, multi-centre study consisting of 2 parts. Part 1: Clinical Pharmacology Study (drug-drug interaction between AK106-001616 and methotrexate) Part 2: Proof of Concept Study
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA (class I to III)
- •Stable dose of methotrexate (at least 12 weeks)
排除标准
- •Pregnant or breastfeeding
- •Abnormal screening laboratory test values considered to be clinically significant
研究组 & 干预措施
AK106-001616
Experimental
干预措施: AK106-001616 (Drug)
Placebo
Placebo Comparator
Part1: AK106-001616 and Placebo
干预措施: Placebo (Drug)
Active comparator
Active Comparator
Part2: AK106-001616 and Active comparator
干预措施: Active comparator (Drug)
研究者
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