NCT03275025已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
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
- 116
- 试验地点
- 14
- 主要终点
- Percentage of Participants With Adverse Events
研究概览
简要总结
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 Years to 80 Years
- •Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
- •Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
排除标准
- •Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening
- •Any of the following laboratory values at screening:
- •Patients with severe liver impairment (AST or ALT > 2 times the upper limit of normal)
- •Patients with renal disease,immunodeficiency disease and peptic ulcer
- •Patients with pleural effusion and ascites
研究组 & 干预措施
YRA-1909 low dose
Experimental
干预措施: YRA-1909 low dose (Drug)
YRA-1909 low dose
Experimental
干预措施: Placebo (Drug)
YRA-1909 medium does
Experimental
干预措施: YRA-1909 mid dose (Drug)
YRA-1909 medium does
Experimental
干预措施: Placebo (Drug)
YRA-1909 high dose
Experimental
干预措施: YRA-1909 high dose (Drug)
YRA-1909 Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events
时间窗: Week 12
Incidence of all grade adverse events
American College of Rheumatology 20 (ACR20) response rate at Week 12
时间窗: Week 12
次要结局
- Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator(Week 4, 8 and 12)
- ACR20 Response at Week 4,8(Week 4 and 8)
- Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12(Week 4,8 and 12)
- Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12(Week 4, 8 and 12)
- ACR 50, 70 Response at Week 4, 8 and 12(Week 4, 8 and 12)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12(Week 4, 8 and 12)
- Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12(Weeks 4, 8 and 12)
研究者
研究点 (14)
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