A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 9
- 主要终点
- Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum
研究概览
简要总结
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant is pregnant and ≤10 weeks gestation at the time of enrollment
- •Participant must have been on stable, maintenance dose certolizumab pegol (CZP) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician
- •Participant expects to continue CZP therapy throughout pregnancy and for at least 12 weeks postpartum
- •Participant has a negative interferon gamma release assay (IGRA) or tuberculin skin test (TST) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. Participants with documented Bacillus Calmette-Guérin (BCG) vaccine and at low risk for tuberculosis (TB) may enroll without having a TB test performed
排除标准
- •Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- •Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:
- •Known active TB disease
- •History of active TB involving any organ system
- •Latent TB infection
- •High risk of acquiring TB infection
- •Current nontuberculous mycobacterial (NTM) infection or history of NTM infection (unless proven to be fully recovered)
- •Study participant is taking a prohibited medication or has taken a prohibited medication
- •Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
- •Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
- •Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant
研究组 & 干预措施
Pharmacokinetics Sampling
This study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label.
From all study participants blood samples will be drawn for pharmacokinetics during the study.
干预措施: Pharmacokinetics of certolizumab pegol (Drug)
结局指标
主要结局
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum
时间窗: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)
Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.
次要结局
- Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period(From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks))
- Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)(From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks))
- Number of Participants With Pregnancy Outcome(From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks))