Actively Recruiting
Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Led by Incyte Corporation · Updated on 2025-12-11
5621
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating infant outcomes in women with atopic dermatitis (AD) who used ruxolitinib cream during pregnancy compared to those who used topical corticosteroids (TCS). This observational retrospective cohort study uses data from US claims databases to assess safety and outcomes related to these treatments in pregnant women with AD. The study is sponsored by Incyte Corporation and focuses on pregnancy-related effects and infant health outcomes. The study observes two groups: infants born to women exposed to ruxolitinib cream during pregnancy and infants born to women exposed to topical corticosteroids before or during pregnancy. Women must have had at least one pharmacy claim for either ruxolitinib cream or a TCS, with continuous enrollment in the database from six months before conception through the end of pregnancy. Infant data are linked to maternal records and followed for up to one year after birth to assess outcomes. Participants will have their data reviewed for major congenital malformations up to 12 months after birth, small-for-gestational-age births at delivery, and overall pregnancy outcomes up to birth. The study excludes women who had pharmacy claims for oral ruxolitinib or other JAK inhibitors during the exposure window. Continuous enrollment in the database allows for detailed tracking of infant health and pregnancy outcomes over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 14 years or older at pregnancy outcome
- Pregnancy occurred after FDA approval of ruxolitinib cream for atopic dermatitis on September 21, 2021
- At least one pharmacy claim for ruxolitinib cream or a topical corticosteroid
- Diagnosis of atopic dermatitis before or on the day of the first pharmacy claim for ruxolitinib cream or topical corticosteroid, starting from six months before estimated conception
- Continuous enrollment in the database from six months before estimated conception through the end of pregnancy
- For infant outcomes, ability to link mother and infant data with follow-up up to one year after birth
You will not qualify if you...
- Any pharmacy claims for oral ruxolitinib or other JAK inhibitors during the exposure window for the outcome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - From pregnancy through 12 months after birth
Participants who underwent treatment with either Ruxolitinib Cream or topical corticosteroids during pregnancy are observed for pregnancy and infant outcomes.
Data collected through claims database with no direct visits required
Trial Site Locations
Total: 1 location
1
Syneos Health (remote site)
Morrisville, North Carolina, United States, 27560
Actively Recruiting
Research Team
I
Incyte Corporation Call Center (US)
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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