RECRUITING

Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Conditions

Atopic Dermatitis Eczema AD Tralokinumab Adbry Adtralza Pregnancy Infant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Monitoring Pregnancy and Infant Outcomes Following Tralokinumab Exposure During Pregnancy in the US and Canada - PROTECT

Quick Facts

Study Start:2022-12-08

Study Completion:2035-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05938478

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 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 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 or during pregnancy 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 1. Diagnosed with AD 2. May or may not have received treatment for AD, but have not been exposed to any dose of phototherapy or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or any time during pregnancy. 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	1. Women who have enrolled in the tralokinumab cohort study with a previous pregnancy 2. Exposure to any dose of methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy 3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment) 4. Results of a diagnostic test are positive for a major structural birth defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect 1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy 2. Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy. 3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment) 4. Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect 1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy 2. Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy 3. Exposure to any dose of phototherapy and/or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or during pregnancy 4. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment) 5. Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect

Inclusion Criteria

Exclusion Criteria

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
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
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 or during pregnancy
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
1. Diagnosed with AD
2. May or may not have received treatment for AD, but have not been exposed to any dose of phototherapy or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or any time during pregnancy.
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

1. Women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. Exposure to any dose of methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
4. Results of a diagnostic test are positive for a major structural birth defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect
1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy.
3. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
4. Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect
1. Pregnant women who have enrolled in the tralokinumab cohort study with a previous pregnancy
2. Exposure to any dose of tralokinumab, methotrexate or mycophenolate mofetil within 5 half-lives prior to the estimated date of conception or anytime during pregnancy
3. Exposure to any dose of phototherapy and/or systemic therapy for the treatment of AD within 5 half-lives prior to the estimated date of conception or during pregnancy
4. Retrospective enrollment after the outcome of pregnancy is known (i.e., the pregnancy has ended prior to enrollment)
5. Results of a diagnostic test are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect

Contacts and Locations

Study Contact

Diana Johnson, MS

CONTACT

877-311-8972

mothertobaby@health.ucsd.edu

Study Locations (Sites)

University of California San Diego (UCSD)

La Jolla, California, 92093

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-08

Study Completion Date2035-09-30

Study Record Updates

Study Start Date2022-12-08

Study Completion Date2035-09-30

Terms related to this study

Keywords Provided by Researchers

AD
Eczema
Atopic dermatitis
Tralokinumab
Adbry
Adtralza
Pregnancy
Infant

Additional Relevant MeSH Terms

Atopic Dermatitis
Eczema