A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

Completed · Phase 1

Conditions studied: Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis

In brief

The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.

Key facts

Study ID: NCT02154425
Run by: UCB BIOSCIENCES, Inc.
People needed: 17
Starts: 2014-09-01
Expected to finish: 2016-01-01
Last updated by the study team: 2018-04-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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 subject
Subject is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator
Subject is female and at least 18 years of age at the time of providing consent
Subject has delivered term infant(s) (at least 37 weeks gestation)
Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing information
The decision to treat with CZP or to breastfeed is made independently from and prior to the subject consenting to participate in this study
Subject agrees to use only the emollient or nipple cream provided by the Sponsor for use during the Sampling Period as described per protocol
Subject is at least 6 weeks postpartum
Subject is on an established dosing regimen of CZP (at least the third dose of CZP since starting/restarting CZP)

You may not qualify if…

Subject is pregnant or plans to become pregnant during the study
Subject is taking a prohibited medication or has taken a prohibited medication Note: any subjects requiring antibiotics must be discussed with the Medical Monitor prior to enrollment
Subject has history of chronic alcohol abuse or drug abuse in the last year
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
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
Subject has history of breast implants, breast augmentation, or breast reduction surgery
Subject has previously participated in this study
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 [NCT02019602] or a registry study
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
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
Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection. If tested within the 6 months prior to screening and test was negative for TB, and there is no change in the patient's clinical status, nor social, family, or travel history, there is no need for an additional TB testing at screening

Where it is running

7 — Los Angeles, California, United States
1 — Chapel Hill, North Carolina, United States
3 — Durham, North Carolina, United States
500 — Maastricht, Netherlands
501 — Rotterdam, Netherlands
20 — Bern, Switzerland

Full record on ClinicalTrials.gov

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