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 (NCT06627335)

🧪 Interventions in This Study

• Ruxolitinib Cream (DRUG)
• TCS (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• Syneos Health (remote site) — Morrisville, North Carolina

📞 Contact the Study Coordinator

Phone: (855) 463-3463

Email: medinfo@incyte.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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• Study to Compare Maternal, Fetal, and Infant Outcomes of Women With Mild to Moderate Atopic Dermatitis Exposed to Ruxolitinib Cream During Pregnancy With an Unexposed Control Population — Morrisville, North Carolina
• Impact of Lactation Antenatal Teaching by Clinicians and Healthcare Providers — Loma Linda, California
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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.