Trial record 2 of 3 for:    certolizumab pegol and psoriatic arthritis

A Multicenter Study to Measure the Transfer of Cimzia® From Women to Infants Via the Placenta (CRIB)

This study is currently recruiting participants.
Verified March 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:
NCT02019602
First received: December 18, 2013
Last updated: March 28, 2014
Last verified: March 2014
  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 draw from mother
Procedure: Blood draw from infant
Procedure: Blood draw 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) Phase 1b (Clinical Pharmacology)

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pharmacokinetic samples of mother, infant and umbilical cord

Pharmacokinetic (PK) samples will be taken from the mother, infant and umbilical cord at specific pre-defined time points.

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 draw from mother
A blood sample from the mother will be taken within 24 hours before/after the delivery.
Procedure: Blood draw from infant
Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
Procedure: Blood draw 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.
Other Name: Cimzia®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written Informed Consent form for the maternal subject and written assent for her infant is signed and dated by the subject or by the legal representative. Where applicable, the written assent form for the infant is also signed and dated by the infant's father or legal representative
  • Subject/legal representative 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/assent
  • Subject is ≥ 30 weeks pregnant with a singleton or twins at the time of informed consent/assent
  • Subject is being treated with Certolizumab Pegol (CZP) at a dose and administration schedule per the locally approved label
  • Subject started, or decided to start, treatment with CZP independently from and prior to being recruited for this study and in accordance with the treating physician
  • Subject expects to receive CZP until at least 35 days prior to expected delivery. Additional criteria to be confirmed at Visit 2 (delivery)
  • Subject delivers a live born infant at or near term (≥ 34 weeks gestation)
  • Subject received CZP within 35 days before delivery
  • 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 or a registry study
  • Subject has any obstetrical or psychiatric condition, or she or her infant 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 a prohibited medication or has taken a prohibited medication
  • 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-Tumor Necrosis Factors (TNFs) other than 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. Tuberculosis (TB) test results that have been obtained within the previous 60 days prior to Screening are acceptable (QuantiFERON®-TB GOLD or Purified Protein Derivative [PPD] test)
  • Subject has known TB infection, at high risk of acquiring TB infection or latent TB infection
  Contacts and Locations
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, North Carolina
1 Recruiting
Chapel Hill, North Carolina, United States
Switzerland
20 Recruiting
Bern, Switzerland
Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( 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: March 28, 2014
Health Authority: United States: Food and Drug Administration
Switzerland: Ethikkommission
Germany: Paul-Ehrlich-Institut
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UCB, Inc.:
Cimzia®
CZP
Placental transfer
Autoimmune diseases and pregnancy

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Crohn Disease
Spondylitis
Spondylitis, Ankylosing
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014