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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
RecruitingObservational study
Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Who can join
Ages 14 and older · Women
Full eligibility criteria
Inclusion Criteria: * Women aged 14 years or older at pregnancy outcome. * Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021. * At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort). * 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. * Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy. * 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. Exclusion Criteria: • One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
About the study
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.
What is being tested
- Ruxolitinib Cream (drug)
- TCS (drug)
Sponsor: Incyte Corporation · Participants: 5,621 · Started: Mar 27, 2023
Contact the study team
- Incyte Corporation Call Center (US) · Phone: 1.855.463.3463
Official record on ClinicalTrials.gov — NCT06627335
Locations in the U.S.
| North Carolina | Syneos Health (remote site), Morrisville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.