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Completed

NCT Number: NCT02154425

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

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.

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Key information

Conditions

Axial Spondyloarthritis (AxSpA) Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Behavior Bone Diseases Breast Feeding Connective Tissue Diseases Crohn Disease Crohn's Disease Digestive System Diseases Feeding Behavior Gastroenteritis Gastrointestinal Diseases Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Joint Diseases Musculoskeletal Diseases Non-radiographic Evidence-AxSpA Psoriasis Psoriatic Arthritis Rheumatic Diseases Rheumatoid Arthritis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

500, Maastricht, Netherlands

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About this study

The study will only include women who are receiving treatment with Certolizumab Pegol (CZP) for an approved indication in accordance with their treating physician, although this study is non-interventional regarding treatment with CZP, it is considered interventional due to the collection of breast milk from the lactating mothers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast Milk Sampling

Procedure

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).

Certolizumab Pegol

Biological

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.

Other names: Cimzia®

Primary outcomes

  1. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0

    Time frame: Day 0

    Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.

  2. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2

    Time frame: Day 2

    Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.

  3. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4

    Time frame: Day 4

    Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.

  4. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6

    Time frame: Day 6

    Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.

  5. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8

    Time frame: Day 8

    Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.

  6. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10

    Time frame: Day 10

    Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.

  7. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12

    Time frame: Day 12

    Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.

  8. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14

    Time frame: Day 14

    Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

  9. The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28

    Time frame: Day 28

    In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.

  10. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2

    Time frame: Day 2

    Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.

  11. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4

    Time frame: Day 4

    Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.

  12. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6

    Time frame: Day 6

    Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.

  13. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8

    Time frame: Day 8

    Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.

  14. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10

    Time frame: Day 10

    Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.

  15. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12

    Time frame: Day 12

    Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.

  16. The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14

    Time frame: Day 14

    Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.

  17. The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28

    Time frame: Day 28

    In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.

  18. 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

    Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.

Sponsors and collaborators

Lead sponsor

UCB BIOSCIENCES, Inc.

Industry

Collaborators

  • PPD Development, LP
  • Parexel

Registry information

Official study title

A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)

Acronym: CRADLE

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 3, 2014
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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