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Stelara and Tremfya Pregnancy Exposure Registry

This observational study, called the OTIS Autoimmune Diseases in Pregnancy Project, is looking at the effects of Stelara (ustekinumab) and Tremfya (guselkumab) when used by women with conditions like psoriasis, psoriatic arthritis, or Crohn's disease during pregnancy. The study wants to understand if these medications have any impact on the baby's development. You can join if you've been exposed to Stelara or Tremfya within three months before your last menstrual period or at any time during pregnancy. The main goal is to see if there are any major birth defects in babies born to mothers who used these medications, up to one year after birth. The study is currently unclear on its recruitment status and plans to enroll 200 women.

Study design
This is an observational study that plans to enroll 200 women. It is not a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Babies will be followed for one year after birth to check for major structural malformations.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02103361

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

Recruiting
Not specifiedAll AgesObservational
University of California, San Diego
~200 participants
Updated 2025-01-28 on ClinicalTrials.gov
What's tested:UstekinumabGuselkumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major structural malformations
Measured over From 3 months prior to the first day of the last menstrual period and up to one year of age

Conditions

Psoriasis
Pregnancy
Psoriatic Arthritis
Crohn Disease

Explore related trials

Crohn DiseasePsoriasisPsoriatic Arthritis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Christina Chambers, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Diana Johnson, MS
[email protected]
877-311-8972
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Major structural malformationsFrom 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.