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

Part of paid clinical trials in Morrisville, North Carolina.

Sponsor
Incyte Corporation
Study ID
NCT06627335
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Dec 2025
Primary completion
Aug 15, 2027
Completion
Aug 15, 2028

Study Design

Enrollment
5,621 participants (estimated)

Arms

  • Arm: Infants of women with AD exposed to ruxolitinib cream during pregnancy
  • Arm: Infants of women with AD exposed to a TCS prior to or during pregnancy

Primary Outcome Measure

Number of major congenital malformation (MCM)s [ Time Frame: Up to 12 months after birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Syneos Health (remote site)MorrisvilleNorth Carolina27560-

Find similar trials in Morrisville, NC

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Syneos Health (remote site)· Morrisville, NC

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