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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

958 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-13

Study Completion Date

2033-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pregnancy Related Atopic Dermatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infants of women exposed to ruxolitinib cream during pregnancy

Ruxolitinib Cream

Intervention Type DRUG

Ruxolitinib Cream

Infants of women not exposed to ruxolitinib cream during pregnancy

Ruxolitinib Cream

Intervention Type DRUG

Ruxolitinib Cream

Interventions

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Ruxolitinib Cream

Intervention Type DRUG

Other Intervention Names

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Opzelura

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No