NCT03707535已完成3 期
A Randomized, Controlled, Double-Blind, Phase 3 Study to Compare the Efficacy, Pharmacokinetics and Safety Between CT-P13 and China Approved Remicade When Co-administered With Methotrexate in Patients With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Efficacy assessment: DAS28 (CRP) at Week 14
研究概览
简要总结
To demonstrate that CT-P13 is equivalent to China-approved Remicade at Week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.
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
- •Has a diagnosis of rheumatoid arthritis
- •Has active disease as defined in DAS28 Criteria
排除标准
- •Has a history of tuberculosis (TB) or a current diagnosis of TB
- •Has previously received a biological agent
- •Has previously received a tumor necrosis factor alpha (TNF α) inhibitor
- •Allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products
- •Pregnant or lactating
结局指标
主要结局
Efficacy assessment: DAS28 (CRP) at Week 14
时间窗: Week 14
Clinical response according to the change from baseline in disease activity as measured by the Disease Activity Score using 28 joint counts (DAS28) (C-reactive protein\[CRP\])
次要结局
未报告次要终点
研究者
研究点 (2)
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