Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
233 participants
OBSERVATIONAL
2014-11-30
2025-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Diseased Comparison Cohort
Women with an approved disease who have not been exposed to apremilast at any time in pregnancy.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Interventions
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apremilast
Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
FEMALE
Yes
Sponsors
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Celgene
INDUSTRY
The Organization of Teratology Information Specialists
OTHER
University of California, San Diego
OTHER
Responsible Party
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Christina Chambers
Professor, Co-Director Center for Promotion of Maternal Health and Infant Development
Principal Investigators
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Christina Chambers, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
UCSD
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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Related Links
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Organization of Teratology Information Specialists and MotherToBaby website containing study information
Other Identifiers
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141041
Identifier Type: -
Identifier Source: org_study_id
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