A multicenter, postmarketing study to evaluate the concentration of certolizumab pegol in the breast milk of mothers receiving treatment with Cimzia® (certolizumab pegol) (CRADLE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial
• If ‘other’, further details on the scope of the study:
  Pharmacokinetic study: breast milk transfer

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial phase:
  Human pharmacology (Phase I)
• Clinical trial types:
  Low-intervention clinical trial

  Single-arm trial

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  CERTOLIZUMAB PEGOL
• Medical condition to be studied:
  Spondylitis

  Ankylosing spondylitis

  Crohn's disease

  Psoriatic arthropathy

  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Lactating women who were receiving treatment with Certolizumab Pegol (CZP) for an approved indication.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  16

Study design details

• Main study objective:
  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.
• Outcomes:
  - The concentration of Certolizumab Pegol (CZP) in breast milk on Day 0, 2, 4, 6, 8, 10, 12, 14, and 28 (as applicable)- The calculated daily infant dose of Certolizumab Pegol (CZP) in breast milk on Day 2, 4, 6, 8, 10, and 12- The calculated daily infant dose of Certolizumab Pegol (CZP) in breast milk and average daily infant dose over the dosing interval on Day 14 and 28 (as applicable)
• Data analysis plan:
  The concentration of CZP in breast milk will be summarized descriptively using n (number of available measurements), geometric mean, CV, median, minimum, and maximum for all time points where breast milk is collected. A plot of the CZP concentration in breast milk over time will also be presented. The amount of CZP that the infant may potentially consume daily will be calculated on Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, and on or about Day 28 (for women on a CZP Q4W dosing regimen) using the following formula:Estimated Daily Infant Dosage (mg/kg/day) = Cmilk (average) x 150mL/kg/dayWhere Cmilk = drug concentration in breast milk.This is based on the standardized mean milk consumption for a fully breastfed 2-month old infant of 150mL/kg/day.