UP0017

Principal Investigator: Ann Flynn
Keywords: Crohns , Ulcerative Colitis , Pregnancy , Cimzia , Inflammatory Bowel Disease , Rheumatoid Arthritis Department: Gastroenterology
IRB Number: 00075525 Co Investigator:  
Specialty: OB/Gyn, General, Rheumatology, Gastroenterology, Rheumatology
Sub Specialties: Obstetrics, Rheumatoid Arthritis, Inflammatory Bowel Disease/Crohn's/Ulcerative Colitis,
Recruitment Status: Recruiting

Contact Information

Julie Will
julie.will@hsc.utah.edu
8015879060

Brief Summary

Pregnant women with immunological diseases like rheumatoid arthritis, Crohn’s disease,
psoriatic arthritis, and axial spondyloarthritis (including ankylosing spondylitis), and their
treating physicians, would benefit from information about the placental transfer of CZP, and
possible CZP concentrations in infants, when assessing the benefit/risk of whether and how to
take CZP in their individual situations.
This study is considered to be a Postauthorization Safety Study (PASS) because it evaluates risks
of a medicinal product used in patient populations for which safety information is limited or
missing. Since the prescription of treatment is clearly separated from the decision to include the
subject in the study, and falls within the treating physician’s current practice, this study is
noninterventional with regard to CZP administration. However, it is considered interventional
due to fact that the blood samples being collected from the infant(s), mother, and umbilical
cord(s) are not part of routine clinical practice. This study is considered to be a Phase 1b (clinical
pharmacology) study.
This is a multicenter, prospective study evaluating the placental transfer of CZP in mothers who
are prescribed commercial CZP for an approved indication in accordance with the current
approved prescribing information. The primary objective of this study is to assess whether there
is transfer of CZP to the infant via placental transfer from mothers receiving CZP.
The decision of the subject to start or continue CZP while pregnant must be made in accordance
with her treating physician and must be completely independent of the decision to participate in
this study. Certolizumab pegol is not provided by the Sponsor as part of this study. The CZP
dose and administration schedule will be as per the locally approved label.
Subjects in this study may also participate in UP0016, A multicenter, postmarketing study to
evaluate the concentration of CZP in the breast milk of mothers receiving treatment with
Cimzia®

STUDY OBJECTIVES

Primary objective

To assess whether there is transfer of CZP across the placenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants at birth

Secondary objectives

 To assess the concentration of CZP and levels of anti-CZP antibodies in the plasma of
mothers at delivery
 To assess the concentration of CZP and levels of anti-CZP antibodies in the plasma of
umbilical cords at birth

 

Exploratory objectives

To assess the concentration of PEG in the plasma of infants

To assess the concentration of PEG in the plasma of mothers

To assess the concentration of PEG in the plasma of umbilical cords

To assess the levels of anti-CZP antibodies in the plasma of infants at birth

To assess the concentrations of CZP and PEG, and levels of anti-CZP antibodies in the plasma of infants 4 weeks and 8 weeks after birth

Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must be met at the
Screening Visit (Visit 1).
1. An IRB/IEC approved written Informed Consent form for the maternal subject and her
infant(s) is signed and dated by the subject. Where applicable, the written Informed Consent
form with respect to the infant(s) 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 ≥18 years at the time of informed consent.
4. Subject is ≥30 weeks pregnant with a singleton or twins at the time of informed consent.
5. Subject is being treated with CZP per the current approved prescribing information
(Appendix 17.1).
6. Subject started or decided to continue treatment with CZP independently from and prior to
participating in this study and in accordance with the treating physician.
7. Subject expects to receive CZP until at least 35 days prior to expected delivery (date of
injection counted as Day 1).
Additional criteria to be confirmed prior to first sample from infant at Visit 2 (delivery/birth):
8. Subject delivers a live born infant(s) at or near term (≥34 weeks gestation).
9. Subject received CZP within 35 days before delivery (date of injection counted as Day 1).
10. Subject has not received contraindicated medication (see Section 7.3.2 for prohibited
concomitant medications).

The first sample from the infant(s) may only be taken once all eligibility criteria have been
confirmed. Reconfirmation of eligibility with Inclusion Criteria 8, 9, and 10 is not required prior
to taking blood samples from the mother and umbilical cord(s) at delivery/birth.

Exclusion Criteria

Subjects are not permitted to participate in the study if any of the following criteria is met at Visit 1 or Visit 2:

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 or has taken any medication with strong positive evidence of a human fetal
risk of teratogenicity (eg, methotrexate or leflunomide) during pregnancy.

 

. 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]).  If tested within the 6 months prior to Screening (QuantiFERON®
-TB GOLD or purified protein derivative [PPD] test) and the test was negative for tuberculosis
(TB), and there is no change in the subject’s clinical status, nor social, family, or travel
history, there is no need for an additional TB testing at Screening. Results must be
documented in sites’ source records.

11. Subject has known TB infection, at high risk of acquiring TB infection, or latent TB infection:

Known TB infection whether present or past is defined as:

Active TB infection or clinical signs and symptoms suspicious for TB (pulmonary or extra pulmonary)

History of active TB infection involving any organ system or findings in other organ systems consistent with TB infection

Any evidence by radiography or other imaging modalities consistent with previously active TB infection that is not reported in the subject’s medical history

High risk of acquiring TB infection is defined as:

Known exposure to another person with active TB infection within the 3 months prior to Screening

Time spent in a healthcare delivery setting or institution where individuals infected with TB are housed and where the risk of transmission of infection is high

Latent TB infection is defined as:

Absence of signs, symptoms (ie, evidence of organ-specific involvement), or physical findings suggestive of TB infection with a positive QuantiFERON®-TB GOLD In Tube test (or 2 indeterminate QuantiFERON®-TB GOLD In Tube test results) or positive PPD test (where the PPD skin test has been approved for use by UCB), and a chest x-ray (or other imaging) without evidence of TB infection. NOTE: Chest x-ray in pregnant women is not allowed before the third trimester. If required, the decision to perform a chest x-ray will be based on the Investigator’s clinical decision only, considering the maternal/fetus risk balance.