Apremilast Pregnancy Exposure Registry
NCT02775500 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 233
Last updated 2025-01-28
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.
Conditions
Interventions
- DRUG
-
apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Sponsors & Collaborators
-
Celgene
collaborator INDUSTRY -
The Organization of Teratology Information Specialists
collaborator OTHER -
University of California, San Diego
lead OTHER
Principal Investigators
-
Christina Chambers, PhD, MPH · UCSD
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2024-12-31
- Completion
- 2025-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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