A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
Condition: Axial Spondyloarthritis (AxSpA); Non-radiographic Evidence-AxSpA; Ankylosing Spondylitis; Crohn's Disease; Psoriatic Arthritis; Rheumatoid Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Crohn Disease
Intervention: Blood sampling from mother; Blood sampling from infant; Blood sampling from umbilical cord; Certolizumab Pegol
Intervention description: 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
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cimzia®; CZP; Placental transfer; Autoimmune diseases and pregnancy

Summary:

      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.
    

Eligibility criteria:

        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