NL-OMON41111已完成不适用
A MULTICENTER, POSTMARKETING STUDY TO EVALUATE THE CONCENTRATION OF CERTOLIZUMAB PEGOL IN THE BREAST MILK OF MOTHERS RECEIVING TREATMENT WITH CIMZIA® (CERTOLIZUMAB PEGOL) PHASE 1B (CLINICAL PHARMACOLOGY) - UP0016
CB Biosciences Inc.0 个研究点目标入组 2 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. An IRB/IEC approved written Informed Consent form for participation of the maternal
- •subject and her infant (for collection of infant demographic and AE data) is signed and dated
- •by the subject. Where applicable, the written Informed Consent form with respect to the
- •infant is also signed and dated by the holder of parental rights as designated by the maternal
- •2. Subject is considered reliable and capable of adhering to the protocol and visit schedule
- •according to the judgment of the Investigator.
- •3. Subject is female and at least 18 years of age at the time of providing consent.
- •4. Subject has delivered term infant(s) (at least 37 weeks gestation).
- •5. Subject is being treated with CZP per the current approved prescribing information
- •(Appendix 17.1).
- •6. The decision to treat with CZP or to breastfeed is made independently from and prior to the
- •subject consenting to participate in this study.
- •7. Subject agrees to use only the emollient or nipple cream provided by the Sponsor for use
- •during the Sampling Period.
- •Additional criteria to be confirmed at Visit 2 (just prior to sampling):
- •8. Subject is at least 6 weeks postpartum.
- •9. Subject is on an established dosing regimen of CZP (at least the third dose of CZP since
- •starting/restarting CZP).
排除标准
- •1. Subject is taking a prohibited medication or has taken a prohibited medication as defined in
- •Section 7.3.2. Note: any subjects requiring antibiotics must be discussed with the Medical
- •Monitor prior to enrollment.2. Subject has history of chronic alcohol abuse or drug abuse in the last year.
- •3. In subjects who intend to breastfeed, the infant has any abnormality noted on physical
- •examination that, in the opinion of the Investigator, may jeopardize or compromise the
- •subject*s ability to participate in this study.
- •4. Subject has any medical, obstetrical or psychiatric condition that, in the opinion of the
- •Investigator, can jeopardize or would compromise the subject*s ability to participate in this
- •study or the outcome of the pregnancy (as applicable). Note: subjects with mastitis infection
- •should not have samples collected until the infection is completely resolved.
- •5. Subject has history of breast implants, breast augmentation, or breast reduction surgery.
- •6. Subject has previously participated in this study.
- •7. Subject has participated in a study of an investigational medicinal product (IMP) (or a
- •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 a medical device)
- •unless the study is UCB UP0017 or a registry study.
- •8. Subject has received treatment with any biological therapeutic agent, or other anti-TNF
- •agents with the exception of CZP, within 5 half-lives prior to obtaining the first sample.
- •9. 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 10 - definition of latent
- •tuberculosis [LTB]). Tuberculosis (TB) test results that have been obtained within the
- •previous 60 days prior to Screening (with negative results) are acceptable (QuantiFERON®-
- •TB GOLD or purified protein derivative [PPD] test).
- •10. Subject with known TB infection, at high risk of acquiring TB infection, or LTB infection.
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