A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02154425
• Date of registration: 30/05/2014
• Prospective Registration: Yes
• Primary sponsor: UCB BIOSCIENCES, Inc.
• Public title: A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers CRADLE
• Scientific title: A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)
• Date of first enrolment: September 2014
• Target sample size: 17
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02154425
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France, Netherlands, Switzerland, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Psoriatic Arthritis

Crohn's Disease

Ankylosing Spondylitis

Axial Spondyloarthritis (AxSpA)

Non-radiographic Evidence-AxSpA

Rheumatoid Arthritis

Intervention(s)

Biological: Certolizumab Pegol

Procedure: Breast milk sampling

Primary Outcome(s)

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6 [Time Frame: Day 6]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8 [Time Frame: Day 8]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14 [Time Frame: Day 14]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10 [Time Frame: Day 10]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12 [Time Frame: Day 12]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12 [Time Frame: Day 12]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28 [Time Frame: Day 28]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4 [Time Frame: Day 4]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10 [Time Frame: Day 10]

The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28 [Time Frame: Day 28]

The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days) [Time Frame: From Day 0 to Day 14 or 28]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0 [Time Frame: Day 0]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8 [Time Frame: Day 8]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2 [Time Frame: Day 2]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2 [Time Frame: Day 2]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6 [Time Frame: Day 6]

The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4 [Time Frame: Day 4]

The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14 [Time Frame: Day 14]

Secondary ID(s)

2013-004126-28

UP0016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

PPD

Parexel

Results

• Results available: Yes
• Date Posted: 06/02/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02154425