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

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

August 29, 2019

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Pregnancy Related
Interventions
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

Trial Locations (1)

92093

RECRUITING

Christina Chambers, San Diego

All Listed Sponsors
lead

Sun Pharmaceutical Industries Limited

INDUSTRY