Examining the effects of ruxolitinib cream versus topical corticosteroids in pregnant women with atopic dermatitis
Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
This study is testing whether using ruxolitinib cream during pregnancy is safer for babies than using regular steroid creams in women with atopic dermatitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5621 (estimated) |
| Ages | 14 Years and up |
| Sex | Female |
| Sponsor | Incyte Corporation Industry-sponsored |
| Drugs / interventions | ruxolitinib |
| Locations | 1 site (Morrisville, North Carolina) |
| Trial ID | NCT06627335 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 14 years or older who have a diagnosis of atopic dermatitis and were exposed to either ruxolitinib cream or topical corticosteroids during pregnancy.
Not a fit: Patients who are not pregnant or those without a diagnosis of atopic dermatitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of ruxolitinib cream for treating atopic dermatitis during pregnancy, potentially leading to better treatment options for affected women.
How similar studies have performed: While there may be studies on topical treatments during pregnancy, this specific comparison of ruxolitinib cream and topical corticosteroids in atopic dermatitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Morrisville, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.