Monitoring pregnancy outcomes for women exposed to Stelara and Tremfya
Stelara® and Tremfya® Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
This study is tracking pregnancies in women who have used Stelara or Tremfya to see how these medications might affect the health and development of their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | ustekinumab, guselkumab |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT02103361 on ClinicalTrials.gov |
What this trial studies
This observational project aims to track pregnancies in women who have been treated with Stelara or Tremfya, either during pregnancy or within three months prior to their last menstrual period. The study will evaluate the potential effects of these medications on pregnancy outcomes, including the health and development of the child up to one year after birth. It seeks to identify both visible and subtle defects that may arise from medication exposure during pregnancy, ensuring comprehensive monitoring of fetal outcomes.
Who should consider this trial
Good fit: Ideal candidates are pregnant women or those who have recently given birth and have been treated with Stelara or Tremfya.
Not a fit: Patients who have not been exposed to Stelara or Tremfya during pregnancy or within three months prior to their last menstrual period will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety of Stelara and Tremfya during pregnancy, guiding treatment decisions for women with autoimmune diseases.
How similar studies have performed: Other studies have successfully monitored medication exposure during pregnancy, but this specific registry approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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. * 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.
Where this trial is running
La Jolla, California
- University of California, San Diego — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Christina Chambers, PhD, MPH — University of California, San Diego
- Study coordinator: Diana Johnson, MS
- Email: d4johnson@ucsd.edu
- Phone: 877-311-8972
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.