No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Female
Study type
Observational
Participants needed
200 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for women who have been exposed to Stelara or Tremfya during pregnancy or shortly before. Participants will help researchers understand the effects of these medications on pregnancy and the health of babies after birth.
Are You a Good Fit for This Trial?
You may be able to join if
I have been exposed to Stelara or Tremfya during my pregnancy
I have been exposed to Stelara or Tremfya within 3 months before my last menstrual period
I can document when I was exposed to Stelara or Tremfya
You may not be able to join if
I have not been exposed to Stelara or Tremfya during pregnancy
I have not been exposed to Stelara or Tremfya within 3 months of my last menstrual period
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 duri…
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.
Trial Locations
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Eligibility Criteria
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.
* Docume…
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.
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