A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Blood sampling from mother
* Procedure: Blood sampling from infant
* Procedure: Blood sampling from umbilical cord
* Biological: Certolizumab Pegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: An IRB/IEC approved written Informed Consent form for the maternal subject and her infant(s) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant(s) is also signed and dated by the holder of parental rights as designated by the maternal subject Subject is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator Subject is female ≥18 years at the time of informed consent Subject is ≥30 weeks pregnant with a singleton or twins at the time of informed consent Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing Information Subject started or decided to continue treatment with CZP independently from and prior to participating in this study and in accordance with the treating physician Subject expects to receive CZP until at least 35 days prior to expected delivery (date of injection counted as Day 1) Additional criteria to be confirmed prior to first sample from infant at Visit 2 (delivery/birth): Subject delivers a live born infant(s) at or near term (≥34 weeks gestation ) Subject received CZP within 35 days before delivery (date of injection counted as Day 1) Subject has not received contraindicated medication Exclusion Criteria: 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 [NCT02154425] or a registry study Subject has any obstetrical or psychiatric condition, or she or her infant(s) 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 Subject has history of chronic alcohol abuse or drug abuse during pregnancy 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 Subject is taking or has taken any medication with strong positive evidence of a human fetal risk of teratogenicity (e.g., methotrexate or leflunomide) during pregnancy 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 Subject has a documented history of primary or secondary antiphospholipid syndrome or hypercoagulable state Subject has received treatment with any biological therapeutic agent, including anti-TNFs other than certolizumab pegol (CZP), during pregnancy Subject has previously participated in this study 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 Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB infection (LTB). If tested within the 6 months prior to Screening and the test was negative for TB, and there is no change in the subject's clinical status, nor social, family, or travel history, there is no need for an additional TB testing at Screening

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacokinetic samples<br>Pharmacokinetic (PK) samples will be taken from the mother at Day 0 within 24 hours before/after delivery, from the infant within 24 hours after birth, at Week 4 and Week 8 and from the umbilical cord within one hour after delivery. Included are mothers who decided to continue on, or to start treatment with certolizumab pegol (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. | Procedure: Blood sampling from mother<br>* A blood sample from the mother will be taken within 24 hours before/after the delivery.<br>Procedure: Blood sampling from infant<br>* Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.<br>Procedure: Blood sampling from umbilical cord<br>* A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.<br>Biological: Certolizumab Pegol<br>* 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<br>* Other names: Cimzia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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 | 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 | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cimzia®, CZP, Placental transfer, Autoimmune diseases and pregnancy