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

Launched by SUN PHARMACEUTICAL INDUSTRIES LIMITED · Jun 19, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called tildrakizumab in pregnant women and its effects on their babies. The researchers want to understand what happens to both mothers and infants when tildrakizumab is used during pregnancy. This study is organized by the Organization of Teratology Information Specialists (OTIS), which helps provide information and support to pregnant women and healthcare providers across North America.

To participate, women must be pregnant and either have taken tildrakizumab for an approved medical condition at any time during their pregnancy or have a similar medical condition but have not used tildrakizumab. Participants will be followed through their pregnancy and for one year after their baby is born. If you join the study, you will need to agree to certain conditions, including sharing your medical records and participating in interviews. This research aims to gather important information to ensure the health and safety of both mothers and their babies.

Gender

FEMALE

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 and requirements of the study including the interview schedule, and release of medical records
• • Cohort 2: Disease-Matched Comparison Cohort
• • 1. Pregnant women
• • 2. Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
• • 3. 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
• • 4. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
• Exclusion criteria:
• Cohort 1: Tildrakizumab-Exposed Cohort:
• • 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
• • 2. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
• • 3. Women who have used tildrakizumab for an indication other than a currently approved indication
• • 4. Retrospective enrollment after the outcome of pregnancy is known
• • Cohort 2: Disease-Matched Comparison Cohort
• • 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
• • 2. Exposure to tildrakizumab anytime during the current pregnancy
• • 3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
• • 4. Retrospective enrollment after the outcome of pregnancy is known