Anifrolumab Malignancy and Serious Infections Study
Recruiting · NCT07000110 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Age range
18 Years to 130 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
4 locations listed.
- Research Site - Barcelona, Spain
- Research Site - Charenton-le-Pont, France
- Research Site - Copenhagen, Denmark
- Research Site - Essen, Germany