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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03936335
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • dupilumab — DRUG
    No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.

Study Details

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations \[MCMs\], small for gestational age \[SGA\]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.

Key Dates

Start date
Sep 30, 2019
Status verified
Jul 2025
Primary completion
Jan 21, 2027
Completion
Jan 21, 2027

Study Design

Enrollment
3,930 participants (estimated)

Arms

  • Arm: Dupilumab cohort
    Exposed to dupilumab during the relevant exposure window: * First trimester * Pregnancy
  • Arm: Other systemic therapy or phototherapy cohort
    Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window: * First trimester * Pregnancy
  • Arm: Unexposed cohort
    * Not exposed to systemic medications (including dupilumab) or phototherapy; and * Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window: * First trimester * Pregnancy

Primary Outcome Measure

Prevalence of MCMs [ Time Frame: Up to 21 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Regeneron Research SiteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Regeneron Research Site· Boston, MA

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