Clinical trial NCT06259669: 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
Official title: A US-Prospective, Registry-Based, Observational, Exposure Cohort 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Atopic Dermatitis
Keywords: ruxolitinib
Atopic Dermatitis
pruritus
eczema
topical therapy
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-14
Enrollment: 958
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exposure cohort study of women within the US with atopic dermatitis (AD) who were exposed to ruxolitinib cream at any time during their pregnancy period.

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Number of major congenital malformation (MCM)s
timeFrame: Up to 12 months after birth
Secondary outcomes:
measure: Number of minor congenital malformations
timeFrame: Up to 12 months after birth
measure: Number of Pregnancy outcomes
timeFrame: Up to birth
measure: Adverse pregnancy outcomes
timeFrame: Up to birth
measure: Gestational Age
timeFrame: At time of delivery
measure: Infant Sex
timeFrame: At time of delivery
measure: Infant Body Weight
timeFrame: At time of delivery
measure: Infant Body Length
timeFrame: At time of delivery
measure: Infant Head Circumference
timeFrame: At time of delivery
measure: APGAR Score
timeFrame: At time of delivery
measure: Number of small for gestational age (SGA)s
timeFrame: At time of delivery
measure: Infant Body Length
timeFrame: Through 12 months after birth
measure: Infant Body Weight
timeFrame: Through 12 months after birth
measure: Infant Head Circumference
timeFrame: Through 12 months after birth
measure: Abnormal development
timeFrame: Through 12 months after birth
Other outcomes:
Locations:
city: Morrisville
country: United States
facility: Syneos Health (remote site)
state: North Carolina
Study officials:
References: