Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT
Trial Parameters
Brief Summary
The goal of this observational study is to learn about exposure to tralokinumab during pregnancy, as well as atopic dermatitis (AD) during pregnancy. The main question the study aims to answer is whether pregnant people who have been exposed to tralokinumab during pregnancy experience any differences in pregnancy and infant outcomes compared to women with atopic dermatitis who have not been exposed to tralokinumab during pregnancy. Participants are not required to take tralokinumab during the study. Participants will be asked to: * Complete 1-3 phone interviews during pregnancy and 1-2 phone interviews after delivery * Release medical records for pregnancy and for their child * Complete an online survey about their baby's development at 4 months and 12 months of age * May be asked to have a study doctor examine their child All information is collected remotely, and no visits to the study site are required.
Eligibility Criteria
Inclusion Criteria: Eligibility for the cohort study includes the following: 1. Currently pregnant at the time of enrollment 2. Reside in the US or Canada at the time of enrollment 3. Verbal informed consent to participate OTIS Pregnancy Registry 4. Current diagnosis of AD at the time of enrollment Cohort 1: Tralokinumab-Exposed Cohort 1. Diagnosed with AD 2. Exposure to tralokinumab for any number of days, at any dose, and at any time during pregnancy or within 16 weeks prior to the date of conception 3. Agree to the conditions and requirements of the study including the interview schedule, dysmorphology exam (for the first 80 pregnancies resulting in live born infants), developmental screening, and release of medical records Cohort 2: AD Comparator I- Phototherapy or Systemic Treatment 1. Diagnosed with AD 2. Exposed to phototherapy and/or systemic therapy for the treatment of AD for any number of days, at any dose, and at any time within 5 half-lives prior to the date of conception