An observational follow-up study of women who become pregnant while participating in a certolizumab pegol (CZP) clinical study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Other
• If ‘other’, further details on the scope of the study:
  Pregnancy follow up study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Axial spondyloarthritis

  Ankylosing spondylitis

  Rheumatoid arthritis

  Crohn's disease

  Psoriatic arthropathy

Population studied

• Short description of the study population:
  Women who became pregnant while enrolled in a Certolizumab Pegol (CZP) study or whose pregnancies had otherwise been reported to UCB due to potential CZP exposure during pregnancy.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  360

Study design details

• Main study objective:
  The primary objectives for this observational follow-up study are to estimate the risks of major congenital malformations (MCMs) and to evaluate pregnancy outcomes among women who become pregnant while enrolled in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.
• Outcomes:
  Percentage of newborns with major congenital malformationsPercentage of pregnancy outcome with major congenital malformations, Numbers of maternal pregnancy-related eventsPercentage of Vaginal and C-section deliveriesGestational age at birthBirth weightSmall Size for gestational agePercentage of AEs in infantsPercentage of infants less than or equal to the 10th percentile for sex and age with respective to weight, height, head circumference, gross/ fine motor skills, language, cognitive/social skills
• Data analysis plan:
  Descriptive statistics will be performed for all prospectively reported pregnancy cases for which the minimum eligibility criteria are met and for which the outcome of the pregnancy is available. Summary statistics for categorical variables will consist of frequencies and percentages. For continuous variables, descriptive statistics (number of available observations, mean, median, standard deviation, minimum and maximum with percentiles as optional) will be presented.