Study type

Study topic

Disease /health condition

Study topic, other

Crohn's Disease

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

SKYRIZI

Study drug International non-proprietary name (INN) or common name

RISANKIZUMAB

Anatomical Therapeutic Chemical (ATC) code

(L04AC18) risankizumab
risankizumab

Medical condition to be studied

Crohn's disease
Population studied

Age groups

Adolescents (12 to < 18 years)
Adults (18 to < 65 years)

Special population of interest

Pregnant women

Estimated number of subjects

600
Study design details

Study design

The study will be a population-based, non-interventional, cohort study of pregnant women with moderate-to-severe Crohn's disease (CD. The primary comparison will be among women with moderate-to-severe CD exposed to risankizumab versus those exposed to the comparator treatment group during pregnancy.

Main study objective

The study aim is to evaluate the safety of risankizumab during pregnancy in women with moderate-to-severe CD. The outcomes of this cohort study are major congenital malformations (MCMs) of the infant among live birth pregnancies, Pregnancy outcomes: live birth, spontaneous abortion, elective abortion, stillbirth and Infant outcomes: premature birth, small for gestational age (SGA), neonatal deaths, serious infections.

Data analysis plan

The prevalence (%) of the main outcome (MCMs) and additional outcomes, including other adverse infant outcomes and pregnancy outcomes (live birth, spontaneous abortion, elective abortion, stillbirth), and their 95% confidence intervals (CIs) will be calculated among eligible risankizumab-exposed pregnancies and the corresponding matched comparator biologic-exposed pregnancies.