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

Recruiting

• Conditions: Psoriasis; Psoriatic Arthritis; Pregnancy; Crohn Disease
• Interventions: Drug: Ustekinumab; Drug: Guselkumab

• Registration Number: NCT02103361
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-13
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-26
• Last Update Posted: 2025-01-28
• Primary Completion: 2030-05
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stelara (ustekinumab) exposed	Ustekinumab	Stelara (ustekinumab)-exposed pregnant women (this group is now closed to recruitment)
Tremfya (guselkumab) exposed	Guselkumab	Tremfya (guselkumab-exposed pregnant women

Primary Outcome Measures

Name	Time	Method
Major structural malformations	From 3 months prior to the first day of the last menstrual period and up to one year of age	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.

Secondary Outcome Measures

Name	Time	Method
Minor Congenital Structural Malformations	At dysmorphological exam which will occur at one time point between birth and one 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 potential minor malformations.

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States