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Recruiting 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

— Observational Pregnancy Related Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ruxolitinib Cream.
Who it may be relevant to
Registry conditions: Pregnancy Related, Atopic Dermatitis. Basic parameters: 15 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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.

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.

Interventions

  • Drug Ruxolitinib Cream
    Ruxolitinib Cream

Primary outcome measures

  • Number of major congenital malformation (MCM)s [Time frame: Up to 12 months after birth]
Secondary outcome measures (12)
  • Number of minor congenital malformations [Time frame: Up to 12 months after birth]
  • Number of Pregnancy outcomes [Time frame: Up to birth]
  • Adverse pregnancy outcomes [Time frame: Up to birth]
  • Gestational Age [Time frame: At time of delivery]
  • Infant Sex [Time frame: At time of delivery]
  • Infant Body Weight [Time frame: At time of delivery]
  • Infant Body Length [Time frame: At time of delivery]
  • Infant Head Circumference [Time frame: At time of delivery]
  • APGAR Score [Time frame: At time of delivery]
  • Number of small for gestational age (SGA)s [Time frame: At time of delivery]
  • Infant Body Length [Time frame: Through 12 months after birth]
  • Infant Body Weight [Time frame: Through 12 months after birth]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Syneos Health (remote site) — Morrisville

Identifiers

NCT: NCT06259669 · INCB18424-MA-IAI-402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗