Recruiting

Stelara & Tremfya

Sponsor:

UCLA

Code:

NCT02103361

Conditions

Psoriasis

Pregnancy

Psoriatic Arthritis

Crohn Disease

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ustekinumab

Guselkumab

Study Details

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.

Conditions

Psoriasis

Pregnancy

Psoriatic Arthritis

Crohn Disease

Study ID

NCT02103361

Start date

Nov, 2013

Status verified date

Jan, 2025

Completion date

Feb, 2031

Anticipated

Primary completion date

May, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

Stelara (ustekinumab) exposed

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

Tremfya (guselkumab) exposed

Tremfya (guselkumab-exposed pregnant women

Interventions

Ustekinumab

Guselkumab

Primary outcome measure

  • Major structural malformations [ Time Frame: From 3 months prior to the first day of the last menstrual period and up to one year of age ]

Central Contacts and Locations

Central contacts

Diana Johnson, MS

877-311-8972d4johnson@ucsd.edu

Christina Chambers, PhD, MPH

877-311-8972chchambers@ucsd.edu

Locations

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Principal Investigator:

Christina Chambers, PhD, MPH

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Keywords

  • autoimmune disease
  • pregnancy
  • psoriasis
  • Stelara
  • ustekinumab
  • birth outcome
  • malformation
  • birth defect
  • psoriatic arthritis
  • Crohn's Disease
  • Tremfya
  • guselkumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-01-28.