Apremilast Pregnancy Exposure Registry

NCT02775500 | Active Not Recruiting FDA Drug

• 1 other identifier: 141041
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

Brief 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

Psoriatic Arthritis; Psoriasis

Keywords

pregnancy; apremilast; Otezla; autoimmune disease; psoriatic arthritis; psoriasis; TNF; tumor necrosis factor; birth outcome; birth defect

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Pattern of minor structural malformations identified by study physical exam in the children of study participants

  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

  At the end of pregnancy

• Gestational age at delivery among infants in the cohort groups

  At the end of pregnancy

• Pregnancy Complication rates between cohort groups

  From the first day of the last menstrual period (LMP) through delivery

• Neonatal Complication rates between cohort groups

  Birth of the child to 1 month of age.

Study Arms (4)

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

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

Interventions

apremilast DRUG

Comparison of women exposed during pregnancy versus women who are not exposed to apremilast

Also known as: Otezla

Apremilast-Exposed Cohort; Apremilast-Exposed Registry Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Pregnant

Sponsors & Collaborators

• University of California, San Diego: lead
• Celgene: collaborator
• The Organization of Teratology Information Specialists: collaborator

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Links

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

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis; Autoimmune Diseases; Congenital Abnormalities

Interventions

apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christina Chambers, PhD, MPH

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Co-Director Center for Promotion of Maternal Health and Infant Development

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: May 17, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)