A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
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: Breast milk sampling; Certolizumab Pegol
Intervention description: Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose for mothers on CZP Q2W), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP).; 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.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cimzia®; CZP; Breastfeeding; Nursing; Autoimmune diseases and pregnancy

Summary:

      The primary objectives of this study are to assess whether there is transfer of Certolizumab
      Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing
      regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate
      the daily infant dose of maternal CZP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An IRB/IEC approved written Informed Consent form for participation of the maternal
             subject and her infant (for collection of infant demographic and AE data) is signed
             and dated by the subject. Where applicable, the written Informed Consent form with
             respect to the infant 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 and at least 18 years of age at the time of providing consent

          -  Subject has delivered term infant(s) (at least 37 weeks gestation)

          -  Subject is being treated with Certolizumab Pegol (CZP) per the current approved
             prescribing information

          -  The decision to treat with CZP or to breastfeed is made independently from and prior
             to the subject consenting to participate in this study

          -  Subject agrees to use only the emollient or nipple cream provided by the Sponsor for
             use during the Sampling Period as described per protocol

          -  Subject is at least 6 weeks postpartum

          -  Subject is on an established dosing regimen of CZP (at least the third dose of CZP
             since starting/restarting CZP)

        Exclusion Criteria:

          -  Subject is pregnant or plans to become pregnant during the study

          -  Subject is taking a prohibited medication or has taken a prohibited medication Note:
             any subjects requiring antibiotics must be discussed with the Medical Monitor prior to
             enrollment

          -  Subject has history of chronic alcohol abuse or drug abuse in the last year

          -  In subjects who intend to breastfeed, the infant has any abnormality noted on physical
             examination that, in the opinion of the Investigator, may jeopardize or compromise the
             subject's ability to participate in this study

          -  Subject has any medical, obstetrical or psychiatric condition that, in the opinion of
             the Investigator, can jeopardize or would compromise the subject's ability to
             participate in this study or the outcome of the pregnancy (as applicable). Note:
             subjects with mastitis infection should not have samples collected until the infection
             is completely resolved

          -  Subject has history of breast implants, breast augmentation, or breast reduction
             surgery

          -  Subject has previously participated in this study

          -  Subject has participated in a study of an investigational medicinal product (IMP) (or
             a 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 a
             medical device) unless the study is UCB UP0017 [NCT02019602] or a registry study

          -  Subject has received treatment with any biological therapeutic agent, or other
             anti-TNF agents with the exception of CZP, within 5 half-lives prior to obtaining the
             first sample

          -  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 (LTB) infection. If tested within the 6 months prior to
             screening and test was negative for TB, and there is no change in the patient's
             clinical status, nor social, family, or travel history, there is no need for an
             additional TB testing at screening