NCT06738719进行中（未招募）3 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients With Moderately to Severely Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celltrion
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
研究概览
简要总结
This is a Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CT-P13 Auto-Injector
Experimental
CT-P13 SC(Subcutaneous) Auto-Injector
干预措施: CT-P13 SC Auto-Injector (Biological)
Placebo Auto-Injector
Placebo Comparator
Placebo Auto-Injector
干预措施: Placebo Auto-Injector (Biological)
结局指标
主要结局
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12
时间窗: Week 0 ~ Week 12
To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12
次要结局
- Change from baseline in HAQ-DI at Week 12(Week 0 ~ Week 12)
- Evaluate Pharmacokinetics of CT-P13 SC(Up to 52 Weeks)
- Evaluate Safety of CT-P13 SC(Up to 52 Weeks)
研究者
研究点 (1)
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