Anifrolumab Pregnancy Study

Part of paid clinical trials in Cary, North Carolina.

Sponsor
AstraZeneca
Study ID
NCT07049653
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Study Details

This is a non-interventional multi-database post-authorisation study to assess pregnancy-related safety data from women with SLE exposed to Anifrolumab.

Key Dates

Start date
Jun 4, 2026
Status verified
Jun 2026
Primary completion
Dec 10, 2030
Completion
Dec 10, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Exposed cohort
    Pregnant individuals with a diagnosis of SLE who are exposed to anifrolumab at any time during pregnancy
  • Arm: Unexposed cohort
    Pregnant individuals with a diagnosis of moderate/severe SLE who are not exposed to anifrolumab at any time during pregnancy but who are exposed to other products for the treatment of SLE

Primary Outcome Measure

Risk of major congenital malformations (MCM) [ Time Frame: From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteCaryNorth Carolina27513-

Find similar trials in Cary, NC

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Research Site· Cary, NC

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