Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Recruiting
Observational Study
Psoriasis
Pregnancy
Psoriatic Arthritis
Crohn Disease
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.
At a Glance
- Sex
- Female
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- University of California, San Diego · Other
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About This Trial
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…
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…
Contacts