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
Recruiting · NCT06627335 · Observational (researchers observe without assigning treatment) · Lead sponsor: Incyte Corporation
View the official record on ClinicalTrials.gov →Interventions studied
Ruxolitinib CreamTCS
What this trial is about
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.
Who can take part
Age range
14 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed across 1 US state.
- Syneos Health (remote site) - Morrisville, North Carolina, United States