Anifrolumab Malignancy and Serious Infections Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anifrolumab.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark, France, Germany, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed 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.
Interventions
- Drug Anifrolumab
Anifrolumab prescribed per local practice
Primary outcome measures
- Malignancies [Time frame: Indexdate to November 2031]
- Serious infection [Time frame: Indexdate to November 2027]
- Infections leading to hospitalisation [Time frame: Index date to November 2027]
- Infection-related death [Time frame: Indexdate to November 2027]
Secondary outcome measures (3)
- Specific types of malignancies [Time frame: Indexdate to November 2031]
- Serious infection components [Time frame: Indexdate to November 2027]
- Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately) [Time frame: Indexdate to November 2027]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Denmark · 1 center
- Research Site — Copenhagen
France · 1 center
- Research Site — Charenton-le-Pont
Germany · 1 center
- Research Site — Essen
Spain · 1 center
- Research Site — Barcelona
Identifiers
NCT: NCT07000110 · D3461R00046