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NCT06627335 | RECRUITING | Pregnancy Related

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
Sponsor:

Incyte Corporation

Brief Summary:

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.

Condition or disease

Pregnancy Related

Atopic Dermatitis

Intervention/treatment

Ruxolitinib Cream

TCS

Study Type : OBSERVATIONAL
Estimated Enrollment : 5621 participants
Official Title : Pregnancy Outcomes Study of Women With Atopic Dermatitis Exposed to Ruxolitinib Cream Versus Topical Corticosteroids During Pregnancy: A US Claims Database Analysis
Actual Study Start Date : 2023-03-27
Estimated Primary Completion Date : 2027-08-15
Estimated Study Completion Date : 2028-08-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 14 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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.
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

Location Details

NCT06627335

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How to Participate

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Locations

RECRUITING

United States, North Carolina

Syneos Health (remote site)

Morrisville, North Carolina, United States, 27560