A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 471
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24
研究概览
简要总结
This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.
详细描述
CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
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
- •Patient is male or female aged 18 to 75 years old, both inclusive.
- •Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.
排除标准
- •Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
- •Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
- •Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
研究组 & 干预措施
CT-P47
CT-P47(Tocilizumab)
干预措施: CT-P47 (Biological)
EU-approved RoActemra
EU-approved RoActemra(Tocilizumab)
干预措施: CT-P47 (Biological)
EU-approved RoActemra
EU-approved RoActemra(Tocilizumab)
干预措施: EU-approved RoActemra (Biological)
结局指标
主要结局
Mean Change From Baseline in Disease Activity Score 28 (DAS28) Using Erythrocyte Sedimentation Rate (ESR) at Week 24
时间窗: Week 24
The DAS28(ESR) score was derived using the following formulae: DAS28 (ESR)=(0.56 ×√TJC28)+(0.28 × √SJC28)+(0.70 × ln\[ESR\])+(0.014 ×GH) Where: * TJC28 = number of tender joints (0-28): tender joint count (TJC) * SJC28 = number of swollen joints (0-28): swollen joint count (SJC) * ESR = ESR measurement (mm/hour) * GH = patient's global disease activity measured on VAS (mm: 0-100) DAS28 (ESR) values could be ranged from 0 to 10 while higher values mean a higher disease activity.
次要结局
- Mean Change From Baseline in DAS28 (ESR) at Week 32(Week 32)
- ACR20, ACR50, and ACR70 Response Rate at Week 24(Week 24)
- ACR20, ACR50, and ACR70 Response Rate at Week 32(Week 32)