Anifrolumab Malignancy and Serious Infections Study
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-130
SponsorAstraZeneca
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care (SOC) who do not initiate anifrolumab.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Anifrolumab
DrugAnifrolumab prescribed per local practice
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Malignancies
Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source
Time frame
Indexdate to November 20312
Serious infection
Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death
Time frame
Indexdate to November 20273
Infections leading to hospitalisation
Infection diagnosis as a part of a hospitalization episode, use of IV antimicrobials, or death, or infection diagnosis in primary or secondary care settings up to 7 days before hospitalization
Time frame
Index date to November 20274
Infection-related death
Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month
Time frame
Indexdate to November 2027Secondary outcomes
1
Specific types of malignancies
Haematologic, solid and skin malignancies
Time frame
Indexdate to November 20312
Serious infection components
Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death
Time frame
Indexdate to November 20273
Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)
Time frame
Indexdate to November 2027Sponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov