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

NCT02019602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-06-21

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Parexel

    collaborator INDUSTRY

  • UCB BIOSCIENCES, Inc.

    lead INDUSTRY

Principal Investigators

  • UCB Cares · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • United States
  • France
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02019602 on ClinicalTrials.gov