A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02019602
• Date of registration: 18/12/2013
• Prospective Registration: Yes
• Primary sponsor: UCB BIOSCIENCES, Inc.
• Public title: A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta CRIB
• Scientific title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
• Date of first enrolment: January 2014
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02019602
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Netherlands, Switzerland, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Subject is considered reliable and capable of adhering to the protocol and visit
schedule according to the judgment of the Investigator

- Subject is female =18 years at the time of informed consent

- Subject is =30 weeks pregnant with a singleton or twins at the time of informed
consent

- Subject is being treated with Certolizumab Pegol (CZP) per the current approved
prescribing Information

- 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

- 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):

- Subject delivers a live born infant(s) at or near term (=34 weeks gestation )

- Subject received CZP within 35 days before delivery (date of injection counted as Day
1)

- Subject has not received contraindicated medication

Exclusion Criteria:

- 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 [NCT02154425] or a registry study

- Subject has any obstetrical or psychiatric condition, or she or her infant(s) 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

- Subject has history of chronic alcohol abuse or drug abuse during pregnancy

- 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

- Subject is taking or has taken any medication with strong positive evidence of a human
fetal risk of teratogenicity (e.g., 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

- Subject has a documented history of primary or secondary antiphospholipid syndrome or
hypercoagulable state

- Subject has received treatment with any biological therapeutic agent, including
anti-TNFs other than certolizumab pegol (CZP), during pregnancy

- Subject has previously participated in this study

- 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 infection (LTB). If tested within the 6 months prior to
Screening and the test was negative for 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Psoriatic Arthritis

Rheumatoid Arthritis

Ankylosing Spondylitis

Non-radiographic Evidence-AxSpA

Axial Spondyloarthritis (AxSpA)

Intervention(s)

Procedure: Blood sampling from infant

Procedure: Blood sampling from mother

Procedure: Blood sampling from umbilical cord

Biological: Certolizumab Pegol

Primary Outcome(s)

The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth [Time Frame: Day 0]

Secondary Outcome(s)

The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery [Time Frame: Day 0]

The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth [Time Frame: Day 0]

The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth [Time Frame: Day 0]

The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery [Time Frame: Day 0]

The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth [Time Frame: Day 0]

Secondary ID(s)

2013-003812-30

UP0017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel

PPD

Results

• Results available: Yes
• Date Posted: 21/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02019602