Apremilast Pregnancy Exposure Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Conditions
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Psoriatic Arthritis, Psoriasis

Intervention / Treatment
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* Drug: apremilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant Exclusion Criteria: -
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Apremilast-Exposed Cohort<br>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. | Drug: apremilast<br>* Comparison of women exposed during pregnancy versus women who are not exposed to apremilast<br>* Other names: Otezla;|
| Diseased Comparison Cohort<br>Women with an approved disease who have not been exposed to apremilast at any time in pregnancy. | |
| Healthy Comparison Cohort<br>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. | |
| Apremilast-Exposed Registry Group<br>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. | Drug: apremilast<br>* Comparison of women exposed during pregnancy versus women who are not exposed to apremilast<br>* Other names: Otezla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of major structural malformations identified in the children of study participants | The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects in children of study participants. The study is analyzing the difference in the number of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records. | Throughout pregnancy through 1 year of life | 
| A pattern of major malformations identified in the children of study participants | The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to a pattern of major malformations in children of study participants. The study is analyzing the difference in the pattern of major malformations in children whose moms were exposed to apremilast compared to women without exposure to apremilast. Information will be collected from maternal interview and through medical records. | Throughout pregnancy through 1 year of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of minor structural malformations identified by study physical exam in the children of study participants | One secondary objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to a potential pattern of minor malformations. Information collected during the dysmorphology exam. | Assessed when the dysmorphology exam is conducted, which will occur between birth of the child and through study completion, an average of 1 year of age | 
| Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups | Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to pregnancy outcome (rates of live born infants, spontaneous abortions, stillbirths, and terminations. Information will be collected from maternal interview and through medical records. | At the end of pregnancy | 
| Gestational age at delivery among infants in the cohort groups | Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to gestational age at delivery. Rates of preterm and full-term delivery between cohorts will be compared, as well as any statistical differences in gestational age at delivery. Information will be collected from maternal interview and through medical records. | At the end of pregnancy | 
| Pregnancy Complication rates between cohort groups | Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to pregnancy complications. Rates of pregnancy complications between cohorts will be compared. Information will be collected from maternal interview and through medical records. | From the first day of the last menstrual period (LMP) through delivery | 
| Neonatal Complication rates between cohort groups | Another objective of the study is to evaluate the effects of certain medications when used in the first trimester of pregnancy with respect to neonatal complications. Rates of neonatal complications between cohorts will be compared. Information will be collected from maternal interview and through medical records. | Birth of the child to 1 month of age. | 
| Pre- and post-natal fetal and infant growth percentiles | Pre- and post-natal fetal and infant growth will be compared between cohorts. The study will analyze rates between cohorts for small for gestational age, those that are small for weight, length, and/or head circumference up to one year of age. Information will be collected from maternal interview and through medical records. | From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child | 
| Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study | Any opportunistic or serious infection, including any infection requiring hospitalization in the child. Rates of infections will be compared between cohort groups. Information will be collected from maternal interview and through medical records. | Up to one year of age of the child | 
| Any malignancies diagnosed in infants of mothers enrolled in the study | Any malignancy diagnosed in the child up to 1 year of age. Rate of malignancies will be compared between cohort groups. Information will be collected from maternal interview and through medical records. | Up to one year of age of the child | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, apremilast, Otezla, autoimmune disease, psoriatic arthritis, psoriasis, TNF, tumor necrosis factor, birth outcome, birth defect