Apremilast Pregnancy Exposure Registry

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT02775500
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • apremilast — DRUG
    Comparison of women exposed during pregnancy versus women who are not exposed to apremilast

Study Details

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.

Key Dates

First listed
May 17, 2016
Start date
Nov 30, 2014
Status verified
Jan 2025
Primary completion
Dec 31, 2024
Completion
Jul 31, 2025

Study Design

Enrollment
233 participants (actual)

Arms

  • Arm: Apremilast-Exposed Cohort
    Women who have been exposed to apremilast in pregnancy for an approved indication in the first trimester of pregnancy for any length of time from the date of conception.
  • Arm: Diseased Comparison Cohort
    Women with an approved disease who have not been exposed to apremilast at any time in pregnancy.
  • Arm: Healthy Comparison Cohort
    Healthy women who have no diagnosis of an approved indication or other chronic illness, have not taken apremilast in pregnancy, nor have they been exposed to any known human teratogen during pregnancy.
  • Arm: Apremilast-Exposed Registry Group
    Women who have been exposed to apremilast in pregnancy, for any length of time following the first day of the last menstrual period until the end of pregnancy who do not qualify for the prospective cohort study.

Primary Outcome Measure

The number of major structural malformations identified in the children of study participants [ Time Frame: Throughout pregnancy through 1 year of life ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San DiegoLa JollaCalifornia92093-

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