RECRUITING

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

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Conditions

Pregnancy RelatedAtopic Dermatitisruxolitinibprurituseczematopical therapyJAK inhibitor

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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

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.

Official Title

Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Quick Facts

Study Start:2023-03-27
Study Completion:2028-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06627335

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:14 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women aged 14 years or older at pregnancy outcome.
  2. * Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
  3. * At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
  4. * A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
  5. * Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
  6. * For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)
CONTACT
1.855.463.3463
medinfo@incyte.com

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

Syneos Health (remote site)
Morrisville, North Carolina, 27560
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

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 Date2023-03-27
Study Completion Date2028-08-15

Study Record Updates

Study Start Date2023-03-27
Study Completion Date2028-08-15

Terms related to this study

Keywords Provided by Researchers

  • ruxolitinib
  • Atopic Dermatitis
  • pruritus
  • eczema
  • topical therapy
  • JAK inhibitor

Additional Relevant MeSH Terms

  • Pregnancy Related
  • Atopic Dermatitis