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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-27

Study Completion Date

2028-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT06259669

Pregnancy Related Atopic Dermatitis

RECRUITING

Study of Ruxolitinib Cream in Children With Atopic Dermatitis

NCT05034822

Atopic Dermatitis

COMPLETED PHASE1

An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

NCT03936335

Adverse Pregnancy Outcomes Atopic Dermatitis

RECRUITING

A Study to Evaluate the Efficacy, and Safety Study of Ruxolitinib Cream in Adults With Moderate Atopic Dermatitis

NCT06238817

Atopic Dermatitis

COMPLETED PHASE3

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children and Adolescents (6 to <18 Years Old) With Moderate Atopic Dermatitis

NCT06832618

Atopic Dermatitis

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Related Atopic Dermatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Infants of women with AD exposed to ruxolitinib cream during pregnancy

Ruxolitinib Cream

Intervention Type DRUG

Ruxolitinib Cream

Infants of women with AD exposed to a TCS prior to or during pregnancy

TCS

Intervention Type DRUG

Topical corticosteroid

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ruxolitinib Cream

Intervention Type DRUG

TCS

Topical corticosteroid

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Opzelura

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.