Summary

for females (full criteria)
healthy people welcome
at La Jolla, California
study started
estimated completion:
Christina Chambers

Description

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.

Official Title

Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Details

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.

Keywords

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

Eligibility

You can join if…

Open to females

  • Pregnant

You CAN'T join if...

Location

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

Lead Scientist

  • Christina Chambers
    Dr. Chambers is a professor of pediatrics at University of California, San Diego and Director 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.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT02775500
Study Type
Observational [Patient Registry]
Last Updated