Comparing outcomes for pregnant women with atopic dermatitis using ruxolitinib cream

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 aims to compare maternal, fetal, and infant outcomes between women with mild to moderate atopic dermatitis who used ruxolitinib cream during pregnancy and those who did not. The study will enroll women in the US, allowing for both prospective and retrospective enrollment based on their pregnancy outcomes. Participants will be monitored for the frequency of major congenital malformations among infants born to these women. The goal is to gather data that can inform the safety of ruxolitinib cream in pregnant patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women, aged 15 to 50 years, with confirmed diagnosis of mild to moderate AD.
* Ability to comprehend and willingness to give informed consent for the study; a legal minor needs parental or legally authorized representative's consent.
* Prospective enrollment (ie, enrollment into the registry while the pregnancy is ongoing) or retrospective enrollment (ie, enrollment into the registry within 12 months of pregnancy outcome).
* Information available to confirm eligibility for either the exposed to ruxolitinib cream cohort or the not exposed to ruxolitinib cream cohort.

  * Ruxolitinib cream cohort: consisting of pregnancies in women with AD and exposure to at least 1 application of ruxolitinib cream during the pregnancy period.
  * Nonexposed cohort: consisting of pregnancies in women with AD but not exposed to ruxolitinib cream during the pregnancy period
* Reporter (eg, participant, maternal HCP) contact information available to allow for follow-up.
* Permission to contact the participant's and her infant's HCPs.

Exclusion Criteria:

* If no longer pregnant and pregnancy outcome occurred more than 12 months prior to enrollment.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before enrollment with another investigational medication or current enrollment in another investigational drug study.
* Any pregnancy that is exposed to any other JAK inhibitor from 5 half-lives for the specific JAK inhibitor used from LMP through the end of the first trimester for MCMs or end of pregnancy for other outcomes.

Where it's running

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

Study contacts

• Study coordinator: Syneos Health
• Email: opzeluracreampregnancyregistry@syneoshealth.com
• Phone: 1.833.917.8791

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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.