NCT03992729

Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sun Pharmaceutical Industries Limited · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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

• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Pregnant women exposed to tildrakizumab	Subjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
DRUG	Pregnant women not exposed to tildrakizumab	Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy

Timeline

• Start date: 2019-08-29
• Primary completion: 2028-07-31
• Completion: 2028-07-31
• First posted: 2019-06-20
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States