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Trial record 1 of 1 for:    NCT02019602
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A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta (CRIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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. )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis (AxSpA) Non-radiographic Evidence-AxSpA Ankylosing Spondylitis Crohn's Disease Psoriatic Arthritis Rheumatoid Arthritis Procedure: Blood sampling from mother Procedure: Blood sampling from infant Procedure: Blood sampling from umbilical cord Biological: Certolizumab Pegol Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
Study Start Date : January 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.

 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®


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019602


Locations
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United States, Arizona
11
Scottsdale, Arizona, United States
United States, Oklahoma
9
Oklahoma City, Oklahoma, United States
United States, Utah
101
Salt Lake City, Utah, United States
France
203
Lille, France
200
Paris, France
202
Paris, France
Netherlands
500
Maastricht, Netherlands
Switzerland
20
Bern, Switzerland
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
PPD
Parexel
Investigators
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Study Director: UCB Cares +1 877 822 9493 (UCB)
More Information
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Publications of Results:

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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT02019602    
Other Study ID Numbers: UP0017
2013-003812-30 ( EudraCT Number )
First Posted: December 24, 2013    Key Record Dates
Results First Posted: June 21, 2019
Last Update Posted: June 21, 2019
Last Verified: March 2019
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Cimzia®
CZP
Placental transfer
Autoimmune diseases and pregnancy
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Psoriatic
Spondylarthritis
Spondylitis, Ankylosing
Axial Spondyloarthritis
Crohn Disease
Joint Diseases
Musculoskeletal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Spondylarthropathies
 Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infections
Ankylosis
Certolizumab Pegol
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents