NCT04740814已完成1 期
A Multi-Center, Open-Label Study to Evaluate the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis Using an Electrochemiluminescent Immuno-Assay
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 14
- 主要终点
- Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing
研究概览
简要总结
The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol in adults with active rheumatoid arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 69 years of age inclusive, at the time of signing the informed consent
- •Participant must have a diagnosis of moderately-to-severely active rheumatoid arthritis (RA)
- •Participant must have had an inadequate response to, or intolerance to, at least 1 disease modifying antirheumatic drug (DMARD) (nonbiologic or biologic)
- •Participant has a negative interferon-gamma release assay (IGRA) at Screening
- •Participant has a body mass index within the range 18.0 kg/m2 to 35.0 kg/m2 (inclusive)
- •Male or female
- •A female participant is eligible to participate if:
- •i) she is not pregnant, ii) not breastfeeding, iii) at least one of the following conditions applies:
- •Not a woman of childbearing potential (WOCBP) OR
- •A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and until the Safety Follow-up (SFU) Visit
排除标准
- •Participant has a known hypersensitivity to any components of the study medication(including polyethylene glycol) or comparative drugs (and/or an investigational device) as stated in this protocol
- •Participant has clinically significant electrocardiogram (ECG) abnormalities at Screening
- •Participant has previously been exposed to certolizumab pegol (CZP)
- •Participant has failed treatment with ≥1 tumor necrosis factor (TNF) α inhibitor or was a primary failure for any TNFα antagonist. A primary failure is defined as no clinical disease improvement within the first 12 weeks of treatment (study participants who demonstrated clinical response within 12 weeks of treatment and subsequently lost response after 12 weeks of treatment are eligible)
- •Participant has received a live vaccination within 6 weeks prior to Screening or intends to have a live vaccination during the course of the study or within 3 months following CZP treatment in the study
- •Participant has received any investigational drug or experimental procedure within 90 days prior to the first dose of IMPinvestigational medicinal product (IMP)
- •Participant has a laboratory abnormality at Screening, including any of the following:
- •>3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP); or >ULN total bilirubin (>1.5x ULN total bilirubin if the participant has a documented pre-study diagnosis of Gilbert's syndrome)
- •white blood cell count <3.00x103/μL
- •absolute neutrophil count (ANC) <1.5x103/μL
- •lymphocyte count <500 cells/μL
- •hemoglobin <8.5 g/dL
- •Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the study participant from completing the study or will interfere with the interpretation of the study results
研究组 & 干预措施
Certolizumab pegol
Experimental
Subjects in this arm will receive doses of certolizumab pegol for the treatment of Rheumatoid Arthritis, in accordance with the US label.
干预措施: Certolizumab pegol (Drug)
结局指标
主要结局
Minimum Observed Plasma Concentration (Cmin) Post 10 Weeks of Certolizumab Pegol Dosing
时间窗: Plasma samples were collected at Pre dose on Day 70 (Week 10), 72, 75, 77 and 80 post-Week 10 study Investigational Medicinal Product (IMP) administration, and Pre dose on Day 84 (Week 12)
Cmin is the Minimum observed plasma drug concentration during a dosage interval.
Area Under the Concentration-time Curve Over One Dosing Interval (AUC0-tau) of Certolizumab Pegol
时间窗: Plasma samples were collected at Pre dose on Day 70 (Week 10), 72, 75, 77 and 80 post-Week 10 study IMP administration, and Pre dose on Day 84 (Week 12)
AUCtau is the area Under the plasma concentration-time curve from time zero to tau for the dosing interval following administration at Week 10.
次要结局
- Plasma Concentration of Certolizumab Pegol (CZP) During the Study(Predose (Day 0), Day 7, 14, 42, 70, 72, 75, 77, 80, 84, 126, and 168)
- Percentage of Participants With Treatment-emergent Serious Adverse Event (SAEs)(From Baseline to the Safety Follow-up Visit (up to Week 34))
- Percentage of Participants With Treatment-emergent Adverse Event (TEAEs) Leading to Withdrawal(From Baseline to the Safety Follow-up Visit (up to Week 34))
研究者
研究点 (14)
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