NCT06627335 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
| NCT ID | NCT06627335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Incyte Corporation |
| Condition | Pregnancy Related |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,621 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,621 participants in total. It began in 2023-03-27 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Incyte Medical Monitor
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT06627335 clinical trial?
This trial is open to female participants only, aged 14 Years or older, studying Pregnancy Related. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627335 currently recruiting?
Yes, NCT06627335 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT06627335 trial being conducted?
This trial is being conducted at Morrisville, United States.
Who is sponsoring the NCT06627335 clinical trial?
NCT06627335 is sponsored by Incyte Corporation. The principal investigator is Incyte Medical Monitor at Incyte Corporation. The trial plans to enroll 5,621 participants.