Actively Recruiting
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Led by Sun Pharmaceutical Industries Limited · Updated on 2026-01-21
200
Participants Needed
1
Research Sites
465 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication. The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry. These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy. The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
CONDITIONS
Official Title
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women
- For exposed group: Exposure to tildrakizumab for any number of days and dose from the first day of last menstrual period through pregnancy end
- For comparison group: Diagnosed with a tildrakizumab-approved condition and no tildrakizumab exposure during current pregnancy
- Agree to study conditions including interview schedule and release of medical records
You will not qualify if you...
- Women first contacting the study after prenatal diagnosis of major structural defects
- Women enrolled previously in the tildrakizumab pregnancy study with an earlier pregnancy
- Women who used tildrakizumab for an unapproved indication
- Retrospective enrollment after pregnancy outcome is known
- For comparison group: Exposure to tildrakizumab during current pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Christina Chambers
San Diego, California, United States, 92093
Actively Recruiting
Research Team
H
Head, Clinical Development
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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