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

Sun Pharma

Status: Enrolling

Conditions: Pregnancy Related

Treatments: Drug: Pregnant women not exposed to tildrakizumab; Drug: Pregnant women exposed to tildrakizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03992729

TILD 3357-2

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

200 participants in 2 patient groups

Tildrakizumab-Exposed Cohort

Description:

Exposure to tildrakizumab for the treatment of an approved indication

Treatment:

Drug: Pregnant women exposed to tildrakizumab

Disease-Matched Comparison Cohort

Description:

No exposure to tildrakizumab at any time in the current pregnancy

Treatment:

Drug: Pregnant women not exposed to tildrakizumab