Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
NCT ID: NCT03992729
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2019-08-29
2028-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tildrakizumab-Exposed Cohort
Exposure to tildrakizumab for the treatment of an approved indication
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
Disease-Matched Comparison Cohort
No exposure to tildrakizumab at any time in the current pregnancy
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
Interventions
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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
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
Eligibility Criteria
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Exclusion Criteria
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
FEMALE
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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Christina Chambers
San Diego, California, United States
Countries
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Central Contacts
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Other Identifiers
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TILD 3357-2
Identifier Type: -
Identifier Source: org_study_id
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