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 (OPERA-1)

Incyte

Status

Enrolling

Conditions

Atopic Dermatitis

Pregnancy Related

Treatments

Drug: Ruxolitinib Cream

Study type

Observational

Funder types

Industry

Identifiers

NCT06259669

INCB18424-MA-IAI-402

Details and patient eligibility

About

This observational (enrollment into the registry while the pregnancy is ongoing) study is being conducted to compare the frequency of major congenital malformation (MCM)s among infants of women exposed to ruxolitinib cream during pregnancy with infants of women not exposed to ruxolitinib cream during pregnancy.

Full description

This study is an exposure cohort study of women within the US with AD who were exposed to ruxolitinib cream at any time during their pregnancy period, defined as up to 24 days prior to the estimated date of conception (DOC) through the end of pregnancy, compared with women in the US with Atopic Dermatitis (AD) not exposed to ruxolitinib cream during pregnancy. The DOC is estimated to occur 14 days after the last menstrual period (LMP). Eligible pregnant women may self-enroll or voluntarily be enrolled by their health care provider (HCP) by calling Syneos Health. Enrollment should occur as early in pregnancy as possible.

Enrollment

958 estimated patients

Sex

Female

Ages

15 to 50 years old

Volunteers

No Healthy Volunteers

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.