EUCTR2013-003812-30-NL进行中（未招募）1 期
A MULTICENTER POSTMARKETING STUDY TO EVALUATETHE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL INPREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA®(CERTOLIZUMAB PEGOL)
CB Biosciences Inc.0 个研究点目标入组 20 人开始时间: 2014年5月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. An IRB/IEC approved written Informed Consent form for the maternal subject and written assent for her infant is signed and dated by the subject or by the legal representative. Where applicable, the written assent form for the infant is also signed and dated by the infant’s father or legal representative.
- •2. Subject/legal representative is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator.
- •3. Subject is female =18 years at the time of informed consent/assent.
- •4. Subject is =30 weeks pregnant with a singleton or twins at the time of informed consent/assent.
- •5. Subject is being treated with CZP at a dose and administration schedule per the locally approved label.
- •6. Subject started, or decided to start, treatment with CZP independently from and prior to being recruited for this study and in accordance with the treating physician.
- •7. Subject expects to receive CZP until at least 35 days prior to expected delivery.
- •Additional criteria to be confirmed at Visit 2 (delivery):
- •8. Subject delivers a live born infant at or near term (=34 weeks gestation).
- •9. Subject received CZP within 35 days before delivery.
- •10. Subject has not received contraindicated medication
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subject has participated in a study of an investigational medicinal product (IMP) or medical device within the previous 30 days or 5 half-lives (whichever is longer) prior to Screening or is currently participating in another study of an IMP or medical device - unless the study is UCB UP0016 or a registry study.
- •2. Subject has any obstetrical or psychiatric condition, or she or her infant has any medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study or the outcome of the pregnancy.
- •3. Subject has history of chronic alcohol abuse or drug abuse during pregnancy.
- •4. Subject has any pregnancy-related clinically significant abnormality noted on obstetric ultrasound, or other imaging assessment, or the subject has significant laboratory abnormalities during her pregnancy, as judged by the Investigator.
- •5. Subject is taking a prohibited medication or has taken a prohibited medication.
- •6. Subject has evidence of a condition suggesting chronic or acute uteroplacental insufficiency such as intrauterine growth restriction, severe maternal hypertensive disorders of pregnancy, or abruption.
- •7. Subject has a documented history of primary or secondary antiphospholipid syndrome or hypercoagulable state.
- •8. Subject has received treatment with any biological therapeutic agent, including anti-TNFs other than CZP, during pregnancy.
- •9. Subject has previously participated in this study.
- •10. Subject has a positive or indeterminate QuantiFERON®-TB GOLD In Tube test at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the subject (see also exclusion criterion 11 – definition of latent tuberculosis [LTB]). Tuberculosis (TB) test results that have been obtained within the previous 60 days prior to Screening are acceptable (QuantiFERON®-TB GOLD or purified protein derivative [PPD] test).
- •11. Subject has known TB infection, at high risk of acquiring TB infection or latent TB infection as specified in the protocol.
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