Apremilast Pregnancy Exposure Registry

Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis; Psoriatic Arthritis
• Intervention / Treatment: Drug: apremilast

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population includes pregnant women who reside in the U.S. or Canada. All exposed subjects and comparison subjects will be recruited through spontaneous callers to participating OTIS member services in locations throughout North America and through active recruitment strategies, e.g., direct mailings to rheumatologists, dermatologists and other relevant specialists, obstetric health care providers, pharmacists, web site, and professional meetings.

Description

Inclusion Criteria:

• Pregnant

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: apremilast; Comparison of women exposed during pregnancy versus women who are not exposed to apremilast; Other Names: Otezla
Diseased Comparison Cohort; Women with an approved disease who have not been exposed to apremilast at any time in pregnancy.
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.
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.	Drug: apremilast; Comparison of women exposed during pregnancy versus women who are not exposed to apremilast; Other Names: Otezla

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: Celgene; The Organization of Teratology Information Specialists
• Investigators: Principal Investigator: Christina Chambers, PhD, MPH, UCSD

Publications and helpful links

Helpful Links

• Organization of Teratology Information Specialists and MotherToBaby website containing study information

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimated): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; Otezla; psoriatic arthritis; psoriasis; TNF; autoimmune disease; apremilast; tumor necrosis factor; birth outcome; birth defect
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Joint Diseases; Immune System Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylarthritis; Spondylitis; Arthritis; Psoriasis; Autoimmune Diseases; Arthritis, Psoriatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Phosphodiesterase Inhibitors; Phosphodiesterase 4 Inhibitors; Apremilast
• Other Study ID Numbers: 141041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No