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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by UCB Pharma
Sponsor:
Collaborators:
PPD
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT02019602
First received: December 18, 2013
Last updated: January 30, 2015
Last verified: January 2015
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • The plasma concentration of Certolizumab Pegol (CZP) in the Infant(s) at birth [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Blood samples will be taken within 24 hours after birth from the infant(s)


Secondary Outcome Measures:
  • The plasma concentration of Certolizumab Pegol (CZP) in the mother at delivery [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood samples will be taken within 24 hours before/after delivery from the mothers and within 24 hours after birth from the infant(s)

  • The plasma concentration of Certolizumab Pegol (CZP) in the umbilical cord at birth [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood samples will be taken directly after delivery (within <= 1 hour) from the umbilical cord


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019602

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

Locations
United States, Arizona
11 Recruiting
Scottsdale, Arizona, United States
United States, California
7 Recruiting
Los Angeles, California, United States
United States, North Carolina
1 Recruiting
Chapel Hill, North Carolina, United States
3 Recruiting
Durham, North Carolina, United States
United States, Oklahoma
9 Recruiting
Oklahoma City, Oklahoma, United States
United States, Utah
101 Recruiting
Salt Lake City, Utah, United States
France
200 Recruiting
Paris, France
Netherlands
500 Recruiting
Maastricht, Netherlands
Switzerland
20 Recruiting
Bern, Switzerland
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
PPD
Parexel
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT02019602     History of Changes
Other Study ID Numbers: UP0017, 2013-003812-30
Study First Received: December 18, 2013
Last Updated: January 30, 2015
Health Authority: France: Conseil National de l'Ordre des Médecins
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Switzerland: Ethikkommission
United States: Food and Drug Administration
United States: Institutional Review Board
Colombia: Ministry of Health and Social Protection
Colombia: Institutional Review Board

Keywords provided by UCB Pharma:
Cimzia®
CZP
Placental transfer
Autoimmune diseases and pregnancy

Additional relevant MeSH terms:
Arthritis
Spondylitis, Ankylosing
Ankylosis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015