for females (full criteria)
Healthy Volunteers
healthy people welcome
at La Jolla, California
study started
completion around
Principal Investigator
by Christina Chambers, PhD, MPH
Headshot of Christina Chambers
Christina Chambers



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.

Official Title

Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project


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.


Psoriatic Arthritis, Psoriasis, pregnancy, apremilast, Otezla, autoimmune disease, TNF, tumor necrosis factor, birth outcome, birth defect, Arthritis, Autoimmune Diseases


You can join if…

Open to females

- Pregnant

You CAN'T join if...


  • University of California, San Diego
    La Jolla California 92093 United States

Lead Scientist at UCSD

  • Christina Chambers, PhD, MPH
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Vice Chair of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital. She is a perinatal epidemiologist, whose research is focused on environmental exposures and pregnancy and child health outcomes, including birth defects.


in progress, not accepting new patients
Start Date
Completion Date
University of California, San Diego
Organization of Teratology Information Specialists and MotherToBaby website containing study information
Study Type
Observational [Patient Registry]
About 233 people participating
Last Updated