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Recruiting NCT07000110

Anifrolumab Malignancy and Serious Infections Study

Conditions: Systemic Lupus Erythematosus

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
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.
Who can participate
Inclusion Criteria: * 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 * SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date Exclusion Criteria: * 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
Interventions
Anifrolumab
DRUG
Locations 4
Denmark (1)
Research Site
Copenhagen
France (1)
Research Site
Charenton-le-Pont
Germany (1)
Research Site
Essen
Spain (1)
Research Site
Barcelona
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
26.01.2026
Completion date
30.11.2031
Registry ID
NCT07000110
Source
clinicaltrials.gov
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