Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Recruiting now
Conditions studied: Pregnancy Related
In brief
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.
Key facts
- Study ID
- NCT03992729
- Run by
- Sun Pharmaceutical Industries Limited
- People needed
- 200
- Starts
- 2019-08-29
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-01-21
Who can join
Age: any. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Cohort 1: Tildrakizumab-Exposed Cohort:
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known
- Cohort 2: Disease-Matched Comparison Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to tildrakizumab anytime during the current pregnancy
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Retrospective enrollment after the outcome of pregnancy is known
Where it is running
- Christina Chambers — San Diego, California, United States (enrolling)
Full record on ClinicalTrials.gov
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