NCT02775500

Apremilast Pregnancy Exposure Registry

Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 233 (actual)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The purpose of the Apremilast Pregnancy Exposure Registry is to monitor planned and unplanned pregnancies exposed to apremilast and to evaluate the safety of this medication relative to specified pregnancy outcomes, and to evaluate potential effects of prenatal apremilast exposure on infant health status through one year of age.

Detailed description

The Apremilast Pregnancy Exposure Registry (Registry) is a United States (U.S.) based registry designed to monitor planned or unplanned pregnancies exposed to apremilast when used to treat an approved indication in accordance with the current approved prescribing information, who reside in the U.S. or Canada. The goal of the Registry is to conduct an observational, controlled prospective cohort study that will involve follow-up of live born infants to one year of age. 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. Secondary objectives are to evaluate the potential effect of exposure relative to the secondary comparison group of healthy pregnant women, and 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. The Pregnancy Exposure Registry is sponsored by Celgene Corporation and is conducted by the Organization of Teratology Information Specialists (OTIS) Research Group and is administered by investigators at the coordinating site located at the University of California, San Diego. The study is planned for seven years.

Conditions

• Psoriatic Arthritis
• Psoriasis

Interventions

Type	Name	Description
DRUG	apremilast	Comparison of women exposed during pregnancy versus women who are not exposed to apremilast

Timeline

• Start date: 2014-11-01
• Primary completion: 2024-12-01
• Completion: 2025-07-01
• First posted: 2016-05-17
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study