Studies cancer and serious infection risk with anifrolumab in lupus patients
Compares cancer and serious infection risk in adults with lupus taking anifrolumab.
Plain-language title generated from the registry record
Registry title: Anifrolumab Malignancy and Serious Infections Study
Key facts
- Where
- Copenhagen, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Source: NCT07000110, who can take part
Where in Denmark
- CopenhagenCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07000110
- Record updated
- 16 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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.