Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(L04AB) Tumor necrosis factor alpha (TNF-alpha) inhibitors
Tumor necrosis factor alpha (TNF-alpha) inhibitors
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)

Estimated number of subjects

2665
Study design details

Main study objective

Part I: To evaluate the risk of major birth defects after first tirmester TNF-α inhibitor exposure-Part II: To analyze if there is an effect on infant’s immune system during the first year of life

Outcomes

Study part I: Rate of major birth defects (major birth defect classification according to the Eurocat classification), risk of spontaneous abortion, birth weight.Study part II: Severity and frequency of infections, infant’s weight gain, Study part I: rate of electively terminated pregnancies, risk of preterm birthStudy part II: allergic diseases and adverse vaccine effects, achievement of developmental milestones

Data analysis plan

Part I: Birth defect rates (BD) include live births and anomalies in elective terminations of pregnancies and miscarriages. Classification of major BD excluding genetic disorders according to the EUROCAT-classification. Cumulative incidences used for calculating spontaneous abortion rates (Meister R 2008). Propensity score method for bias reduction using boosted regression trees including maternal age, parity, previous spontaneous abortions, previous children/fetuses with major birth defects, alcohol, tobacco, other immunosuppressant medication including systemic corticosteroids.Part II: mainly descriptive