A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P17 With Humira When Co-administered With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 648
- 试验地点
- 1
- 主要终点
- American College of Rheumatology(ACR)20 Response Rate at Week 24.
研究概览
简要总结
This is a Phase III Study to Compare Efficacy and Safety of CT-P17 with Humira in Patients With Active Rheumatoid Arthritis
详细描述
CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to demonstrate similar efficacy and safety of CT-P17 and Humira in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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 rheumatoid arthritis according to the 2010 American College of Rheumatology(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; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
- 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
Humira SC (adalimumab)
Humira SC (adalimumab)
干预措施: Humira SC (Biological)
CT-P17 Subcutaneous(SC) (adalimumab)
CT-P17 SC (adalimumab)
干预措施: CT-P17 SC (Biological)
Humira SC (adalimumab)
Humira SC (adalimumab)
干预措施: CT-P17 SC (Biological)
结局指标
主要结局
American College of Rheumatology(ACR)20 Response Rate at Week 24.
时间窗: Week 24
ACR20 is defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in the three of the following five criteria: 1) patient global assessment of disease activity, 2) physician global assessment of disease activity, 3) functional ability measure using Health Assessment Questionnaire (HAQ), 4) visual analog pain scale, and 5) erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)
次要结局
- Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)(Up to Week 52)
- ACR50 and ACR70 Response Rate at Week 24(Week 24)
- ACR20, ACR50, and ACR70 Response Rate up to Week 52(Up to Week 52)
- Mean Change From Baseline in Disease Activity Measured by DAS28 (CRP)(Week 24)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT03789292
- 其他研究编号
- CT-P17 3.1, 2018-001690-25
日期
- 首次提交
- (7年前)
- 首次发布
- (7年前)
- 主要完成日期
- (6年前)
- 研究完成日期
- (6年前)
- 最近核实
- (5年前)
- 最近更新
- (4年前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 是