NCT02430909已完成2 期
A Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Multiple Doses of UCB4940 Administered as Add-on to Certolizumab Pegol Therapy in Subjects With Moderate-to-Severe Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Celltech
- 入组人数
- 159
- 试验地点
- 33
- 主要终点
- Change from Baseline 2 in DAS28(CRP)
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy and body distribution of Bimekizumab (UCB4940) when added to Certolizumab Pegol treatment in patients with Rheumatoid Arthritis. Neither the patient nor the doctor will know the treatment group.
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 70 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
结局指标
主要结局
Change from Baseline 2 in DAS28(CRP)
时间窗: Week 20
DAS28 (Disease Activity Score 28) is a measure of disease activity in Rheumatoid Arthritis (RA) and is a composite score derived from the number of swollen and tender joints (out of 28), the CRP value and the patient global assessment of disease activity.
Incidence of Adverse Events
时间窗: Screening (D-28) until final study visit (Week 44)
All adverse events (AEs) are recorded during the entire study period.
次要结局
- ACR50 response based on Baseline 2(Week 20)
- Percent improvement in ACR (American College of Rheumatology) criteria (ACRn) based on Baseline 2(Week 20)
- ACR20 response based on Baseline 2(Week 20)
- ACR70 response based on Baseline 2(Week 20)
- DAS28(CRP) remission(Week 20)
研究者
研究点 (33)
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