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 Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
37
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
11
Scottsdale, Arizona, United States
9
Oklahoma City, Oklahoma, United States
101
Salt Lake City, Utah, United States
203
Lille, France
200
Paris, France
202
Paris, France
500
Maastricht, Netherlands
20
Bern, Switzerland
The Plasma Concentration of Certolizumab Pegol (CZP) in the Infant(s) at Birth
Blood samples will be taken within 24 hours after birth from the infant(s).
Time frame: Day 0
The Plasma Concentration of Certolizumab Pegol (CZP) in the Mother at Delivery
Blood samples will be taken within 24 hours before/after delivery from the mothers.
Time frame: Day 0
The Ratio of Plasma Concentration of Certolizumab Pegol (CZP) Between the Infant(s) and Mother at Delivery/Birth
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.
Time frame: Day 0
The Plasma Concentration of Certolizumab Pegol (CZP) in the Umbilical Cord at Birth
Blood samples will be taken directly after delivery (within \<= 1 hour) from the umbilical cord
Time frame: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Mother at Delivery
Blood samples will be taken within 24 hours before/after delivery from the mothers
Time frame: Day 0
The Plasma Concentration Level of Anti-CZP Antibodies in the Umbilical Cord(s) at Birth
Blood samples will be taken directly after delivery (within \<= 1 hour) from the umbilical cord
Time frame: Day 0
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