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)

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
subject.
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).

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.