Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Recruiting
Observational Study
Pregnancy Related
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Female
- Study type
- Observational
- Participants needed
- 200 (estimated)
- Sponsor
- Sun Pharmaceutical Industries Limited · Industry
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About This Trial
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 ba…
Trial Locations
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Eligibility Criteria
Cohort 1: Tildrakizumab-Exposed Cohort
1. Pregnant women
2. 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 up to and including the end of pregnancy
3. Agree to the conditions…
Contacts