NCT02103361Recruiting
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
Source: ClinicalTrials.gov · Last updated 28 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 13 Feb 2014
- Start date
- Nov 2013
- Primary completion date
- May 2030
- Lead sponsor
- University of California, San Diego
- Diseases
- Psoriasis, Crohn's disease, Psoriatic arthritis
- NCT number
- NCT02103361
What you commit to
- Study type: Observational
- Planned participants: 200
- From Nov 2013 to the primary completion date, May 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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)
Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.