Study type

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Prospective pregnancy cohort study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

apremilast

Medical condition to be studied

Psoriasis
Psoriatic arthropathy
Population studied

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

300
Study design details

Main study objective

The primary objective of the Registry is to evaluate any potential increase in the risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies.

Outcomes

Risk of major birth defects, specifically a pattern of anomalies, in apremilast exposed pregnancies compared to the primary comparison group of disease-matched unexposed pregnancies, The effect of exposure on other adverse pregnancy outcomes including spontaneous abortion or stillbirth, preterm delivery, reduced infant birth size, a pattern of minor malformations, postnatal growth of live born children to one year of age, and incidence of serious or opportunistic infections or malignancies in live born children up to one year of age.

Data analysis plan

The primary analysis for the primary endpoint for the cohort study will be a comparison of the birth prevalence of major structural defects in live born infants between the apremilast-exposed group and the primary Comparison Group I. This analysis will use chi-square or Fisher’s Exact test for univariate comparisons and logistic regression for adjustment of confounding. The primary analysis of the primary endpoint will be conducted at the end of the study.