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Prospective Registry Investigating Maternal and Infant Outcomes in Anifrolumab Users

← catalyst calendar

NCT06659029 · readout in 1,700 d

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With PPD Development, LP.

Phase
Status
Recruiting
Study type
Observational
Enrollment
442estimated
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2025-07-01actualWhen the study began enrolling
Primary completion2031-04-15estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2031-04-15estimatedThe whole study's end, after follow-up
First posted2024-10-26actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-06-24actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Systemic Lupus Erythematosus

Intervention

  • Drug: Anifrolumab — also filed as Saphnelo

Primary outcome

what the primary-completion date above is the date OF
Composite outcome of all major congenital malformations (MCMs)
measured From date of conception (DOC) to pregnancy outcome for fetal losses or 12 months of infant age for live births

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