Clinical trial NCT02775500: Apremilast Pregnancy Exposure Registry
Official title: Apremilast Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriatic Arthritis
Psoriasis
Keywords: pregnancy
apremilast
Otezla
autoimmune disease
psoriatic arthritis
psoriasis
TNF
tumor necrosis factor
birth outcome
birth defect
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Celgene
name: The Organization of Teratology Information Specialists
First posted: 2016-05-17
Enrollment: 233
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Pregnant

Exclusion Criteria:

-

Primary outcomes:
measure: The number of major structural malformations identified in the children of study participants
timeFrame: Throughout pregnancy through 1 year of life
measure: A pattern of major malformations identified in the children of study participants
timeFrame: Throughout pregnancy through 1 year of life
Secondary outcomes:
measure: Pattern of minor structural malformations identified by study physical exam in the children of study participants
timeFrame: 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
measure: Pregnancy Outcome; rate of live born infants, spontaneous abortions, stillbirths, and terminations between cohort groups
timeFrame: At the end of pregnancy
measure: Gestational age at delivery among infants in the cohort groups
timeFrame: At the end of pregnancy
measure: Pregnancy Complication rates between cohort groups
timeFrame: From the first day of the last menstrual period (LMP) through delivery
measure: Neonatal Complication rates between cohort groups
timeFrame: Birth of the child to 1 month of age.
measure: Pre- and post-natal fetal and infant growth percentiles
timeFrame: From the first day of the last menstrual period (LMP) through delivery, and up to one year of age of the child
measure: Any serious and opportunistic infections rates occurring in infants whose mothers are enrolled in the study
timeFrame: Up to one year of age of the child
measure: Any malignancies diagnosed in infants of mothers enrolled in the study
timeFrame: Up to one year of age of the child
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Christina Chambers, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: