Anifrolumab Malignancy and Serious Infections Study - SIMA
Study identifier:D3461R00046
ClinicalTrials.gov identifier:NCT07000110
EudraCT identifier:N/A
CTIS identifier:N/A
Will Be Recruiting
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
Medical condition
Systemic Lupus Erythematosus
Phase
Phase 4
Healthy volunteers
No
Study drug
Anifrolumab
Sex
All
Estimated Enrollment
3506
Study type
Observational
Age
18 Years - 130 Years
Date
Study Start Date: 28 Nov 2025
Estimated Primary Completion Date: 30 Nov 2031
Estimated Study Completion Date: 30 Nov 2031
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verification:
Verified 01 Aug 2025 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
IQVIA
Inclusion and exclusion criteria
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No locations available
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