Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pregnant women exposed to tildrakizumab, Pregnant women not exposed to tildrakizumab.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Overview
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.
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
Primary outcome measures
- Major structural defects in children [Time frame: Up to 1 year of age]
Secondary outcome measures (9)
- Spontaneous abortion/miscarriage [Time frame: 20 weeks post-last menstrual period]
- Stillbirth [Time frame: from 20 weeks post-last menstrual period to end of pregnancy]
- Elective termination/abortion [Time frame: At the end of pregnancy or through 9 month pregnancy period]
- neonatal/infant death [Time frame: 6 months of age]
- Small for gestational age [Time frame: at birth]
- Postnatal growth deficiency [Time frame: Up to 1 year of age]
- Malignancies in live born children [Time frame: Up to 1 year of age]
- Hospitalization in live born children [Time frame: Up to 1 year of age]
- Postnatal serious or opportunistic infection in live born children [Time frame: Up to 1 year]
Eligibility criteria
Cohort 1: Tildrakizumab-Exposed Cohort
- Pregnant women
- 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
- Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
Cohort 2: Disease-Matched Comparison Cohort
- Pregnant women
- Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible
- 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
- 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:
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Women who have used tildrakizumab for an indication other than a currently approved indication
- Retrospective enrollment after the outcome of pregnancy is known
Cohort 2: Disease-Matched Comparison Cohort
- Women who have first contact with the project after prenatal diagnosis of any major structural defect
- Exposure to tildrakizumab anytime during the current pregnancy
- Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
- Retrospective enrollment after the outcome of pregnancy is known
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Christina Chambers — San Diego
Identifiers
NCT: NCT03992729 · TILD 3357-2