A MULTICENTER POSTMARKETING STUDY TO EVALUATE THE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL IN PREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA® (CERTOLIZUMAB PEGOL)

Completed

Conditions: autoimmune diseases
reumatological diseases
10003816
10010273

Registration Number: NL-OMON40792

Lead Sponsor: CB Biosciences Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The plasma concentration of CZP in the infant at birth</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-The plasma concentration of CZP in the mother at delivery<br /><br>-The ratio between plasma concentration of CZP between the infant and mother at<br /><br>birth<br /><br>-The plasma concentration of CZP in the umbilical cord at birth<br /><br>-The plasma concentration of anti-CZP antibodies in the mother at delivery<br /><br>-The plasma concentration of anti-CZP antibodies in the umbilical cord at birth<br /><br>-AEs of both mother and infant from time of informed consent/assent through<br /><br>Safety<br /><br>Follow-Up</p><br>