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Active, Not Recruiting

NCT Number: NCT02775500

Apremilast Pregnancy Exposure Registry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Sex eligibility

Female

Study type

Observational

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant

Exclusion criteria

-

Treatment and study plan

Apremilast

Drug

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

Other names: Otezla

Primary outcomes

  1. The number of major structural malformations identified in the children of study participants

    Time frame: Throughout pregnancy through 1 year of life

    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.

  2. A pattern of major malformations identified in the children of study participants

    Time frame: Throughout pregnancy through 1 year of life

    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.

Secondary outcomes

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

    Time frame: 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

    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.

  2. Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups

    Time frame: At the end of pregnancy

    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.

  3. Gestational age at delivery among infants in the cohort groups

    Time frame: At the end of pregnancy

    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.

  4. Pregnancy Complication rates between cohort groups

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

    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.

  5. Neonatal Complication rates between cohort groups

    Time frame: Birth of the child to 1 month of age.

    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.

  6. Pre- and post-natal fetal and infant growth percentiles

    Time frame: From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child

    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.

  7. Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study

    Time frame: Up to one year of age of the child

    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.

  8. Any malignancies diagnosed in infants of mothers enrolled in the study

    Time frame: Up to one year of age of the child

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Celgene
  • The Organization of Teratology Information Specialists

Registry information

Official study title

Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

Important dates

Study start
2014
Primary completion
2024
Study completion
2025
First posted
May 17, 2016
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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