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

Официальное название

Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

Обзор

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.

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Major structural defects in children [Срок оценки: Up to 1 year of age]

Вторичные конечные точки (9)

• Spontaneous abortion/miscarriage [Срок оценки: 20 weeks post-last menstrual period]
• Stillbirth [Срок оценки: from 20 weeks post-last menstrual period to end of pregnancy]
• Elective termination/abortion [Срок оценки: At the end of pregnancy or through 9 month pregnancy period]
• neonatal/infant death [Срок оценки: 6 months of age]
• Small for gestational age [Срок оценки: at birth]
• Postnatal growth deficiency [Срок оценки: Up to 1 year of age]
• Malignancies in live born children [Срок оценки: Up to 1 year of age]
• Hospitalization in live born children [Срок оценки: Up to 1 year of age]
• Postnatal serious or opportunistic infection in live born children [Срок оценки: Up to 1 year]

Критерии участия

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Christina Chambers — San Diego

Идентификаторы

NCT: NCT03992729 · TILD 3357-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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