Clinical trial · Observational
Apremilast Pregnancy Exposure Registry
Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
NCT02775500CI-TRIAL-00085170active not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Psoriasis | — | UNRESOLVED | — |
| Psoriatic Arthritis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| apremilast | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Apremilast-Exposed Cohort
- description
- 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.
- interventionNames
- Drug: apremilast
- label
- Diseased Comparison Cohort
- description
- Women with an approved disease who have not been exposed to apremilast at any time in pregnancy.
- label
- Healthy Comparison Cohort
- description
- 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.
- label
- Apremilast-Exposed Registry Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Pregnant Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.