Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Observational · No treatment assigned · 1 site · University of California, San Diego
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Psoriasis, Pregnancy and Psoriatic Arthritis. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Women only
Some of the main requirements, copied from the record:
- 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…
- Documentation of gestational timing of the exposure to Stelara (ustekinumab) or Tremfya (guselkumab)
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2013-11.
- Main results expected around 2030-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Major structural malformations (From 3 months prior to the first day of the last menstrual period and up to one year of age)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Psoriasis; Pregnancy; Psoriatic Arthritis; Crohn Disease |
| Lead sponsor | University of California, San Diego |
| Collaborators | The Organization of Teratology Information Specialists; Janssen Biotech, Inc. |
| Enrollment | 200 (estimated) |
| Start date | 2013-11 |
| Primary completion (est.) | 2030-05 |
| First posted | 2014-04-03 |
| Last updated | 2025-01-28 |
| Official title | Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project |
| ClinicalTrials.gov ID | NCT02103361 |
Interventions
- Ustekinumab (Drug)
- Guselkumab (Drug)
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of California, San Diego | La Jolla, California | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.