NCT07000110

Anifrolumab Malignancy and Serious Infections Study

A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,195 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Detailed description

This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care who do not initiate anifrolumab.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Anifrolumab	Anifrolumab prescribed per local practice

Timeline

• Start date: 2026-01-26
• Primary completion: 2031-11-30
• Completion: 2031-11-30
• First posted: 2025-06-02
• Last updated: 2026-03-24

Locations

4 sites across 4 countries: Denmark, France, Germany, Spain