Anifrolumab Malignancy and Serious Infections Study

ConditionSystemic Lupus Erythematosus

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-130

SponsorAstraZeneca

About this trial

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.

Eligibility criteria

Qualifiers

First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date

A minimum data availability of 12 months prior to index date

Age ≥18 years at index date

SLE severity: patients with moderate to severe SLE at index date

Disqualifiers

A diagnosis of any malignancy prior to index date

A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date

Organ or bone marrow transplant procedure prior to index date

A diagnosis of serious infection in the previous 6 months

Trial design

Treatments tested in this trial

Anifrolumab

Treatment groups

No treatment groups listed

Sponsors and collaborators

AstraZeneca

Lead sponsor

IQVIA Pty Ltd

Collaborator

Source ClinicalTrials.gov