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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07000110). StuddyBuddy aggregates publicly available trial information.