At a glance
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A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
In Brief
A Phase 1 clinical trial evaluating Blood sampling from mother, Blood sampling from infant, and 2 other interventions for Axial Spondyloarthritis (AxSpA) and 5 related conditions. Completed, enrolled 37 participants across 8 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
A blood sample from the mother will be taken within 24 hours before/after the delivery.
Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
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