The primary objective of this study is to assess whether there is transfer of CZP across theplacenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants.The secondary and exploratory objectives are to assess the…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The plasma concentration of CZP in the infant at birth
Secondary outcome
-The plasma concentration of CZP in the mother at delivery
-The ratio between plasma concentration of CZP between the infant and mother at
birth
-The plasma concentration of CZP in the umbilical cord at birth
-The plasma concentration of anti-CZP antibodies in the mother at delivery
-The plasma concentration of anti-CZP antibodies in the umbilical cord at birth
-AEs of both mother and infant from time of informed consent/assent through
Safety
Follow-Up
Background summary
Pregnant women with immunological diseases like RA and CD, and their treating
physicians,
would benefit from information about the placental transfer of CZP, and
possible CZP levels in infants, when assessing the benefit/risk of whether and
how to take CZP in their individual
situations.
This study is considered to be a Postauthorization Safety Study (PASS) because
it evaluates risks
of a medicinal product used in patient populations for which safety information
is limited or
missing. Although this study is noninterventional with regard to CZP
administration, it is
considered interventional due to fact that the blood samples being collected
from the infant,
mother, and umbilical cord are not part of routine clinical practice.
Study objective
The primary objective of this study is to assess whether there is transfer of
CZP across the
placenta to infants from mothers by evaluating the concentration of CZP in the
plasma of infants.
The secondary and exploratory objectives are to assess the concentrations of
CZP, anti-CZP
antibodies, and polyethylene glycol (PEG) in the 3 sources of blood samples at
the time of birth
(infant, mother, and umbilical cord) and in the infants at 4 weeks and 8 weeks
after birth.
Study design
This is a multicenter, postmarketing, prospective study evaluating the
placental transfer of
certolizumab pegol (CZP [CDP870, Cimzia®]) by measuring the concentration of
CZP in the
infant1, mother, and umbilical cord at birth. Additionally, blood samples will
be collected from
the infant at Week 4 and Week 8 after birth in order to assess the
pharmacokinetics (PK) of CZP
in infants after birth.
Intervention
Not applicable.
Study burden and risks
Additional blood tests mother, infant and cord.
Risks associated with study procedure:
- Collection of blood samples.
Arco Corporate Drive 8010
Raleigh, North Carolina NC 27617
US
Arco Corporate Drive 8010
Raleigh, North Carolina NC 27617
US
Listed location countries
Age
Inclusion criteria
1. Subject is >=30 weeks pregnant with a singleton or twins at the time of informed
consent/assent.
2. Subject is being treated with CZP at a dose and administration schedule per the locally
approved label.
3. 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.
4. Subject expects to receive CZP until at least 35 days prior to expected delivery.
Additional criteria to be confirmed at Visit 2 (delivery):
5. Subject delivers a live born infant at or near term (>=34 weeks gestation).
6. Subject received CZP within 35 days before delivery.
Exclusion criteria
1. 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 (see also exclusion criterion 11 - definition of latent
tuberculosis [LTB]). 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).
2. Subject has known TB infection, at high risk of acquiring TB infection, or latent TB
infection.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR201300381230-NL |
| ClinicalTrials.gov | NCT02019602 |
| CCMO | NL48402.056.14 |