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
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
- 21
- 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
- •To be eligible to participate in this study, all of the following criteria must be met:
- •Subject is informed and given approved written Informed Consent Form (ICF).
- •Subject is considered reliable and capable of adhering to the protocol.
- •Subject must have a diagnosis of adult-onset moderate-to-severe RA of at least 6 months' duration as defined by ACR/EULAR 2010 classification criteria.
- •Subject must have:
- •≥6 tender joints (out of 68)
- •≥6 swollen joints (out of 66)
- •CRP≥10.0mg/L .
- •Subject must have had inadequate response to at least 1 synthetic DMARD.
- •Subject is at least 18 years and less than 70 years of age at Visit 1 (Screening).
- •Female subjects must either be:
- •postmenopausal
- •permanently sterilized or,
- •if of childbearing potential, must be willing to use at least 2 effective methods of contraception,
- •Male subjects with partners of childbearing potential must be willing to use a condom when sexually active, during the study and for 5 months after last administration of study drug.
排除标准
- •Subjects are not permitted to enroll in the study if any of the following criteria is met:
- •Subject has previously participated in this study or has previously been assigned to treatment in a study of the investigational medicinal product (IMP) under investigation in this study (UCB4940 and/or CZP).
- •Subject has a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens.
- •Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection are excluded.
- •Subject is at high risk of infection.
- •Subject has an active infection or has had a serious infection within 12 weeks prior to the first dose of study drug at Week
- •Subject has renal or liver impairment.
- •Subject has a current or past history of gastrointestinal ulceration.
- •Subject has active neoplastic disease or history of neoplastic disease.
- •Subject has a concomitant diagnosis of any other inflammatory condition.
- •Subject has a secondary, non-inflammatory condition or a known diagnosis of fibromyalgia.
研究组 & 干预措施
CZP / CZP + PBO / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+Placebo from Week 8 to Week 18
干预措施: Placebo (Other)
CZP / CZP/ CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two Weeks) until Week 30
干预措施: Certolizumab Pegol (Biological)
CZP / CZP + UCB4940 / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+ UCB4940 from Week 8 until Week 18
干预措施: Certolizumab Pegol (Biological)
CZP / CZP + UCB4940 / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+ UCB4940 from Week 8 until Week 18
干预措施: Bimekizumab (Biological)
CZP / CZP + PBO / CZP
Certolizumab Pegol (400 mg at Weeks 0, 2, and 4 followed by 200 mg every two weeks) until Week 30
+Placebo from Week 8 to Week 18
干预措施: Certolizumab Pegol (Biological)
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)