NCT06627335Recruiting
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
Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 5621 (estimated)
- First submitted
- 2 Oct 2024
- Start date
- 27 Mar 2023
- Primary completion date
- 15 Aug 2027
- Lead sponsor
- Incyte Corporation
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT06627335
What you commit to
- Study type: Observational
- Planned participants: 5621
- From 27 Mar 2023 to the primary completion date, 15 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.
Who the study is looking for
- 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.
Age in the registry: 14 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Syneos Health (remote site) Coordinator of this site? Confirm its status | Morrisville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.