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NCT Number: NCT06627335

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

This study is to assess infant outcomes of women with AD who were exposed to ruxolitinib cream during pregnancy compared with a control cohort of women with AD who were exposed to a topical corticosteroid (TCS) during pregnancy.

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Key information

Conditions

Pregnancy Related Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin Manifestations Skin and Connective Tissue Diseases

Age range

14 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Syneos Health (remote site)

Morrisville, North Carolina, 27560, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 14 years or older at pregnancy outcome.
  • Pregnancy following FDA approval of ruxolitinib cream for AD on 21 SEP 2021.
  • At least 1 pharmacy-dispensing claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort).
  • A diagnosis of AD prior to or on the day of the first pharmacy claim for ruxolitinib cream (ruxolitinib-exposed cohort) or a TCS (TCS-exposed cohort) from 6 months before the estimated date of conception.
  • Continuous enrollment in the database from 6 months before the estimated date of conception through the end of pregnancy.
  • For infant outcomes only, linkage of mother and infant data will be required (ie, pregnancies that cannot be linked to an infant will be excluded for infant outcomes but not for pregnancy outcomes). Infants will be followed for as long as they are continuously enrolled in the database up to 1 year after birth (ie, variable follow-up for each infant). A 1-year fixed period of continuous enrollment after birth will not be imposed so as not to introduce survival bias.

Exclusion criteria

  • One or more pharmacy claims for oral ruxolitinib or other JAK inhibitors in the exposure window for a given outcome.

Treatment and study plan

Ruxolitinib Cream

Drug

Ruxolitinib Cream

Other names: Opzelura

TCS

Drug

Topical corticosteroid

Primary outcomes

  1. Number of major congenital malformation (MCM)s

    Time frame: Up to 12 months after birth

    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.

Secondary outcomes

  1. Number of small-for-gestational age (SGA) births

    Time frame: At time of delivery

    Defined as a birthweight at or below the 10th percentile for a given gestational age.

  2. Number of Pregnancy outcomes

    Time frame: Up to birth

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

Study contacts

Contact information is provided by the study sponsor or research team.

Incyte Corporation Call Center (US)

CONTACT

[email protected]

1.855.463.3463

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 4, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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