NCT04333771已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Moderate to Severe Active Rheumatoid Arthritis Subjects With Inadequate Response to csDMARDs.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- ACR20 response rate at week 24
研究概览
简要总结
This study is to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with moderate to severe active rheumatoid arthritis who had inadequate response to conventional synthetic DMARDs.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent.
- •RA diagnosis consistent with the 2010 ACR/EULAR criteria;
- •Moderate to severe RA defined by 6 or more tender joints, 6 or more swollen joints (68- or 66-joint count), and an ESR of 28 mm/h or greater or a CRP level greater than 5mg/L.
- •Subjects were required to have an inadequate response to treatment with csDMARDs before baseline.
- •If subjects are taking permitted csDMARDs or low-dose corticosteroid orally at baseline , the stable doses should have lasted for more than 4 weeks already.
- •BMI ≥18 kg/m2
排除标准
- •Pregnant women or refuse to receive contraception during the study.
- •Lab abnormality within 4 weeks of randomization as follows: WBC count <3.0×10^9/L；neutrophil count<1.5×10^9/L;hemoglobin level<90.0 g/L ; platelet count <100×10^9/L; AST or ALT levels greater than the upper limit of normal; HBsAg or HCV or HIV antibody positivity.
- •History of another autoimmune rheumatic disease ; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases.
- •Previous treatment with JAK inhibitor or cytotoxic drugs; bDMARDs within 6 months of randomization; other strong immunosuppressants within 3 months of randomization.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
SHR0302 dose1
Experimental
干预措施: SHR0302 (Drug)
SHR0302 dose2
Experimental
干预措施: SHR0302 (Drug)
结局指标
主要结局
ACR20 response rate at week 24
时间窗: Week 24
Response rate of 20% improvement in American College of Rheumatology (ACR20) criteria at week 24
次要结局
- ACR20 response rate at week 52(Week 52)
- ACR70 response rate at week 24 and week 52(Week 24 and week 52)
- Change from baseline in SF-36 score at week 24 and week 52(Week 24 and week 52)
- DAS28-CRP <2.6 proportion at week 24 and week 52(Week 24 and week 52)
- ACR50 response rate at week 24 and week 52(Week 24 and week 52)
- Change from baseline in HAQ-DI score at week 24 and week 52(Week 24 and week 52)
- DAS28-CRP≤3.2 proportion at week 24 and week 52(Week 24 and week 52)
研究者
研究点 (1)
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