Anifrolumab
DrugAnifrolumab prescribed per local practice
Other names: Saphnelo
NCT Number: NCT07000110
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.
Interested in participating?
Request Info18 year–130 year
All sexes
Observational
Research Site, Copenhagen, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anifrolumab prescribed per local practice
Other names: Saphnelo
Time frame: Indexdate to November 2031
Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source
Time frame: Indexdate to November 2027
Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death
Time frame: Index date to November 2027
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: Indexdate to November 2027
Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month
Time frame: Indexdate to November 2031
Haematologic, solid and skin malignancies
Time frame: Indexdate to November 2027
Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death
Time frame: Indexdate to November 2027
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
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
Acronym: SIMA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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