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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 6 February 2017
Main ID:  EUCTR2013-003812-30-NL
Date of registration: 26/05/2014
Prospective Registration: Yes
Primary sponsor: UCB Biosciences Inc.
Public title: A multicentre study to measure the transfer of Cimzia from women to infants via the placenta
Scientific title: A MULTICENTER POSTMARKETING STUDY TO EVALUATE THE PLACENTAL TRANSFER OF CERTOLIZUMAB PEGOL IN PREGNANT WOMEN RECEIVING TREATMENT WITH CIMZIA® (CERTOLIZUMAB PEGOL)
Date of first enrolment: 21/07/2014
Target sample size: 20
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003812-30
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: postmarketing, prospective study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase:  Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
France Germany Netherlands Switzerland United States
Contacts
Name: CT Registries & Results Disclosure   
Address:  Alfred Nobel Strasse 10 40789 Monheim Germany
Telephone: 00492173481515
Email: clinicaltrials@ucb.com
Affiliation:  UCB Biosciences GmbH
Name: CT Registries & Results Disclosure   
Address:  Alfred Nobel Strasse 10 40789 Monheim Germany
Telephone: 00492173481515
Email: clinicaltrials@ucb.com
Affiliation:  UCB Biosciences GmbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. An IRB/IEC approved written Informed Consent form for the maternal subject and written assent for her infant is signed and dated by the subject or by the legal representative. Where applicable, the written assent form for the infant is also signed and dated by the infant’s father or legal representative.
2. Subject/legal representative is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator.
3. Subject is female =18 years at the time of informed consent/assent.
4. Subject is =30 weeks pregnant with a singleton or twins at the time of informed consent/assent.
5. Subject is being treated with CZP at a dose and administration schedule per the locally approved label.
6. 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.
7. Subject expects to receive CZP until at least 35 days prior to expected delivery.
Additional criteria to be confirmed at Visit 2 (delivery):
8. Subject delivers a live born infant at or near term (=34 weeks gestation).
9. Subject received CZP within 35 days before delivery.
10. Subject has not received contraindicated medication
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subject has participated in a study of an investigational medicinal product (IMP) or medical device within the previous 30 days or 5 half-lives (whichever is longer) prior to Screening or is currently participating in another study of an IMP or medical device - unless the study is UCB UP0016 or a registry study.
2. Subject has any obstetrical or psychiatric condition, or she or her infant has any medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study or the outcome of the pregnancy.
3. Subject has history of chronic alcohol abuse or drug abuse during pregnancy.
4. Subject has any pregnancy-related clinically significant abnormality noted on obstetric ultrasound, or other imaging assessment, or the subject has significant laboratory abnormalities during her pregnancy, as judged by the Investigator.
5. Subject is taking a prohibited medication or has taken a prohibited medication.
6. Subject has evidence of a condition suggesting chronic or acute uteroplacental insufficiency such as intrauterine growth restriction, severe maternal hypertensive disorders of pregnancy, or abruption.
7. Subject has a documented history of primary or secondary antiphospholipid syndrome or hypercoagulable state.
8. Subject has received treatment with any biological therapeutic agent, including anti-TNFs other than CZP, during pregnancy.
9. Subject has previously participated in this study.
10. 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).
11. Subject has known TB infection, at high risk of acquiring TB infection or latent TB infection as specified in the protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis Axial spondyloarthritis Psoriatic arthritis
MedDRA version: 17.0 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0 Level: PT Classification code 10051265 Term: Spondyloarthropathy System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 17.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Cimzia
Product Name: Certolizumab pegol / CIMZIA
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Primary Outcome(s)
Main Objective: To assess whether there is transfer of CIMZIA ® (CZP) across the placenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants at birth
Primary end point(s): The plasma concentration of CZP in the infant at birth
Secondary Objective: To assess the concentrations of CZP and anti-CZP antibodies in the plasma of mothers at delivery

To assess the concentrations of CZP and anti-CZP antibodies in the plasma of umbilical cords at birth
Timepoint(s) of evaluation of this end point: Delivery/birth
Samples for assessing PK parameters will be obtained at delivery/birth:
- A blood sample within 24 hours after birth from the infant
Secondary Outcome(s)
Secondary end point(s): 1. The plasma concentration of CZP in the mother at delivery
2. The ratio between plasma concentration of CZP between the infant and mother at birth
3. The plasma concentration of CZP in the umbilical cord at birth
4. The plasma concentration of anti-CZP antibodies in the mother at delivery
5. The plasma concentration of anti-CZP antibodies in the umbilical cord at birth
Timepoint(s) of evaluation of this end point: Delivery/birth
Samples for assessing PK parameters will be obtained at delivery/birth:
- A blood sample within 24 hours after birth from the infant
- A blood sample within 24 hours before/after delivery from the mother
- A blood sample directly after delivery (within =1 hour) from the
umbilical cord
Secondary ID(s)
UP0017
Source(s) of Monetary Support
UCB Bioscience Inc
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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