A multicenter postmarketing study to evaluate the placental transfer of certolizumab pegol in pregnant women receiving treatment with Cimzia® (certolizumab pegol) (CRIB)

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: placental transfer

Clinical trials

• Clinical trial regulatory scope:
  Pre-authorisation clinical trial
• Clinical trial phase:
  Human pharmacology (Phase I)
• Clinical trial types:
  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:
  Pregnant women who started or decided to continue treatment with certolizumab pegol (CZP) for an approved indication in accordance with their treating physician prior to participating in the study.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  20

Study design details

• Main study objective:
  To assess whether there is transfer of CZP across the placenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants at birth
• Outcomes:
  The plasma concentration of certolizumab pegol (CZP) in the infant at birth, - The plasma concentration of CZP in the mother at delivery- The ratio of plasma concentration of CZP between the Infant(s) and mother at birth- The plasma concentration of CZP in the umbilical cord(s) at birth- The plasma concentration of anti-CZP antibodies in the mother at delivery- The plasma concentration of anti-CZP antibodies in the umbilical cord(s) at birth
• Data analysis plan:
  The concentration of CZP in the infant at birth will be summarized descriptively using n (number of available measurements), geometric mean, CV, median, minimum, and maximum for those infants that provide a valid CZP concentration measurement at birth. Secondary variables will be summarized descriptively in a similar manner. Summaries will be based on observed data, and no inferential statistical analysis is planned.