A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
CRIB
A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
2 other identifiers
interventional
37
4 countries
8
Brief Summary
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2014
Typical duration for phase_1
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
June 21, 2019
CompletedJune 21, 2019
March 1, 2019
2.8 years
December 18, 2013
November 21, 2017
March 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Blood samples will be taken within 24 hours after birth from the infant(s).
Day 0
Secondary Outcomes (5)
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Day 0
The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
Day 0
The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Day 0
Study Arms (1)
Pharmacokinetic samples
EXPERIMENTALPharmacokinetic (PK) samples will be taken from the mother at Day 0 within 24 hours before/after delivery, from the infant within 24 hours after birth, at Week 4 and Week 8 and from the umbilical cord within one hour after delivery. Included are mothers who decided to continue on, or to start treatment with certolizumab pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label.
Interventions
A blood sample from the mother will be taken within 24 hours before/after the delivery.
Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
Mothers who decided to continue on, or to start treatment with, CZP for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label. * Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection * Concentration: 200 mg/ml * Route of Administration: Subcutaneous Use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES, Inc.lead
- PPD Development, LPcollaborator
- Parexelcollaborator
Study Sites (8)
11
Scottsdale, Arizona, United States
9
Oklahoma City, Oklahoma, United States
101
Salt Lake City, Utah, United States
203
Lille, France
200
Paris, France
202
Paris, France
500
Maastricht, Netherlands
20
Bern, Switzerland
Related Publications (1)
Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.
PMID: 29030361RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
January 1, 2014
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
June 21, 2019
Results First Posted
June 21, 2019
Record last verified: 2019-03