RECRUITINGOBSERVATIONAL
Anifrolumab Malignancy and Serious Infections Study
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 Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- A diagnosis of any malignancy prior to index date
- A diagnosis of HIV/AIDS or congenital weakened immune system prior to index date
- Organ or bone marrow transplant procedure prior to index date
- A diagnosis of serious infection in the previous 6 months
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Anifrolumab
Anifrolumab prescribed per local practice
Locations (4)
Research Site
Copenhagen, Denmark
Research Site
Charenton-le-Pont, France
Research Site
Essen, Germany
Research Site
Barcelona, Spain