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Recruiting
NCT07000110
Anifrolumab Malignancy and Serious Infections Study
Conditions: Systemic Lupus Erythematosus
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Enrollment: 3506
Sponsor: AstraZeneca
Location: Research Site Copenhagen
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07000110). StuddyBuddy aggregates publicly available trial information.