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

Incyte Corporation958 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

958

Conditions

Pregnancy Related Atopic Dermatitis

Interventions

Ruxolitinib Cream

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of major congenital malformation (MCM)s

Defined as any major structural or chromosomal defect in live-born infants, stillbirths or spontaneous losses equal to or greater than 20 weeks' gestation, or electively terminated pregnancies of any gestational age.

Time frame: Up to 12 months after birth

Secondary Outcomes

Number of minor congenital malformations

Defined as abnormalities that do not significantly affect health and development, and normal variants are ascertained only among those who also have a major defect.

Time frame: Up to 12 months after birth

Number of Pregnancy outcomes

Number of live births, still births, recognized spontaneous abortions and number of elective terminations as defined in the protocol.

Time frame: Up to birth

Adverse pregnancy outcomes

Number of preterm births and maternal pregnancy complications as defined in the protocol.

Time frame: Up to birth

Gestational Age

Infant Gestational Age at birth as recorded in medical records.