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Anifrolumab Malignancy and Serious Infections Study
NCT07000110 · AstraZeneca
In plain English
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Official title
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
About this study
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
Study design
Enrollment target: 3195 participants
Age groups: adult, older_adult
Timeline
Starts: 2026-01-26
Estimated completion: 2031-11-30
Last updated: 2026-05-20
Interventions
Drug: Anifrolumab
Primary outcomes
- • Malignancies (Indexdate to November 2031)
- • Serious infection (Indexdate to November 2027)
- • Infections leading to hospitalisation (Index date to November 2027)
Sponsor
AstraZeneca · industry
With: IQVIA Pty Ltd
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (4)
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Copenhagen, Denmark
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Charenton-le-Pont, France
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Essen, Germany
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Barcelona, Spain