Clinical trial NCT02103361: Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Official title: Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Pregnancy
Psoriatic Arthritis
Crohn Disease
Keywords: autoimmune disease
pregnancy
psoriasis
Stelara
ustekinumab
birth outcome
malformation
birth defect
psoriatic arthritis
Crohn's Disease
Tremfya
guselkumab
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: The Organization of Teratology Information Specialists
name: Janssen Biotech, Inc.
First posted: 2014-04-03
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women who have had exposure to Stelara (ustekinumab) or Tremfya (guselkumab) within 3 months of the last menstrual period, or anytime during pregnancy, and who reside in the U.S. or Canada.

The Stelara (ustekinumab) exposed group completed enrollment as of September 2019. The Tremfya (guselkumab) remains open to recruitment.

Brief summary: The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

Detailed description: The purpose of the Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project is to follow pregnant women or women who have delivered a baby, who have been treated with Stelara or Tremfya within 3 months of their last menstrual period (LMP) or during pregnancy to evaluate the possible effect of this medication on the pregnancy outcome including child development and growth up to one year of age.

Eligibility criteria: Inclusion Criteria:

* Documentation of an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months prior to the first day of the last menstrual period (LMP) for any number of days, at any time, at any dose, and at any time until completion of pregnancy.
* Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)

Exclusion Criteria:

* Women who have not have an exposure to Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy or within 3 months of the first day of the last menstrual period.

Primary outcomes:
measure: Major structural malformations
timeFrame: From 3 months prior to the first day of the last menstrual period and up to one year of age
Secondary outcomes:
measure: Minor Congenital Structural Malformations
timeFrame: At dysmorphological exam which will occur at one time point between birth and one year of age
Other outcomes:
measure: Spontaneous abortions
timeFrame: From 3 months prior to the first day of the last menstrual period until the day of delivery
measure: Infant follow-up, growth
timeFrame: Birth to one year of age
measure: Stillbirths
timeFrame: From 3 months prior to the first day of the last menstrual period until the day of delivery
measure: Infant follow-up, Immune system development
timeFrame: Birth to 1 year of age
measure: Preterm delivery
timeFrame: Birth
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Christina Chambers, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: