Examining the effects of ruxolitinib cream versus topical corticosteroids in pregnant women with atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study analyzes data from a US claims database to compare infant outcomes in women with atopic dermatitis who used ruxolitinib cream during pregnancy against those who used topical corticosteroids. The study includes women aged 14 and older who were continuously enrolled in the database from six months before conception through pregnancy. It aims to assess the safety and efficacy of ruxolitinib cream in this population, focusing on infant health outcomes. The study will link mother and infant data to evaluate the effects of the treatments on infants up to one year after birth.

Why it matters

Who can join: the full rules

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.

Where it's running

• Syneos Health (remote site)
  Morrisville, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.