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

Launched by INCYTE CORPORATION · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is designed to compare the health outcomes of infants born to women with mild to moderate atopic dermatitis (a skin condition) who used ruxolitinib cream during pregnancy, with those born to women who did not use the cream. The main focus is to see if there are any major birth defects in babies exposed to this medication compared to those who were not. This research is important as it helps us understand the safety of using ruxolitinib cream in pregnant women.

To be eligible for this study, women aged 15 to 50 with a confirmed diagnosis of mild to moderate atopic dermatitis can participate. They can join the study while pregnant or within a year after giving birth. Participants will need to provide consent and may need permission to contact their healthcare providers for follow-up information. If you decide to join, you will be helping researchers gather valuable information that could improve care for future mothers and babies.

Gender

FEMALE

Eligibility criteria

• 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.