Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project

University of California San Diego

Status: Enrolling

Conditions: Psoriasis; Psoriatic Arthritis; Crohn Disease; Pregnancy

Treatments: Drug: Ustekinumab; Drug: Guselkumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02103361

CNTO1275PSO4037

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Stelara (ustekinumab) exposed

Description:

Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)

Treatment:

Drug: Ustekinumab

Tremfya (guselkumab) exposed

Description:

Tremfya (guselkumab-exposed pregnant women

Treatment:

Drug: Guselkumab