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

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ClinicalTrials.gov Identifier: NCT02019602
Recruitment Status : Completed
First Posted : December 24, 2013
Results First Posted : June 21, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
PPD
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE December 18, 2013
First Posted Date  ICMJE December 24, 2013
Results First Submitted Date  ICMJE November 21, 2017
Results First Posted Date  ICMJE June 21, 2019
Last Update Posted Date June 21, 2019
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth [ Time Frame: Day 0 ]
Blood samples will be taken within 24 hours after birth from the infant(s).
Original Primary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
The plasma concentration of Certolizumab Pegol (CZP) in the infant at birth [ Time Frame: Blood samples will be taken within 24 hours after birth from the infants ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery [ Time Frame: Day 0 ]
    Blood samples will be taken within 24 hours before/after delivery from the mothers.
  • The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth [ Time Frame: Day 0 ]
    Blood samples were taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s). Values below limit of quantification (BLQ) are replaced by values of lower limit of quantification/2=0.016 in calculations of ratios, however if both concentrations for a subject are BLQ then the ratio for that subject will not be calculated.
  • The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth [ Time Frame: Day 0 ]
    Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
  • The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery [ Time Frame: Day 0 ]
    Blood samples will be taken within 24 hours before/after delivery from the mothers
  • The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth [ Time Frame: Day 0 ]
    Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2013)
  • The plasma concentration of Certolizumab Pegol (CZP) in the mother at delivery [ Time Frame: Blood samples will be taken within 24 hours before/after delivery from the mothers ]
  • The ratio of plasma concentration of Certolizumab Pegol (CZP) between the infant and mother at birth [ Time Frame: Blood samples will be taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infants ]
  • The plasma concentration of Certolizumab Pegol (CZP) in the umbilical cord at birth [ Time Frame: Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord ]
  • The plasma concentration of anti-CZP antibodies in the mother at delivery [ Time Frame: Blood samples will be taken within 24 hours before/after delivery from the mothers ]
  • The plasma concentration of anti-CZP antibodies in the umbilical cord at birth [ Time Frame: Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
Official Title  ICMJE A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Axial Spondyloarthritis (AxSpA)
  • Non-radiographic Evidence-AxSpA
  • Ankylosing Spondylitis
  • Crohn's Disease
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
Intervention  ICMJE
  • Procedure: Blood sampling from mother
    A blood sample from the mother will be taken within 24 hours before/after the delivery.
  • Procedure: Blood sampling from infant
    Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
  • Procedure: Blood sampling from umbilical cord
    A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
  • Biological: Certolizumab Pegol

    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
    Other Name: Cimzia®
Study Arms  ICMJE Experimental: Pharmacokinetic samples

Pharmacokinetic (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:
  • Procedure: Blood sampling from mother
  • Procedure: Blood sampling from infant
  • Procedure: Blood sampling from umbilical cord
  • Biological: Certolizumab Pegol
Publications * Mariette X, Förger F, Abraham B, Flynn AD, Moltó 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2019)
37
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2013)
20
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Netherlands,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02019602
Other Study ID Numbers  ICMJE UP0017
2013-003812-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE
  • PPD
  • Parexel
Investigators  ICMJE
Study Director: UCB Cares +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP