RecruitingNCT02103361

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

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


Sponsor

University of California, San Diego

Enrollment

200 participants

Start Date

Nov 1, 2013

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This is a pregnancy registry study — not a treatment trial — that tracks the health outcomes of babies born to mothers who took the medications Stelara (ustekinumab) or Tremfya (guselkumab) during pregnancy. These medications are biological treatments used for conditions like psoriasis and inflammatory bowel disease. The registry helps researchers understand whether these drugs are safe to use during pregnancy. **You may be eligible if...** - You are pregnant or have recently completed a pregnancy - You were exposed to Stelara (ustekinumab) or Tremfya (guselkumab) at any point during your pregnancy, or within 3 months before your last menstrual period - The timing of your medication exposure during the pregnancy can be documented **You may NOT be eligible if...** - You did not take Stelara or Tremfya at any point during the relevant time period before or during your pregnancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUstekinumab
DRUGGuselkumab

Locations(1)

University of California, San Diego

La Jolla, California, United States

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NCT02103361


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