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
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Research Site
RECRUITING
Copenhagen
France
Research Site
RECRUITING
Charenton-le-pont
Germany
Research Site
RECRUITING
Essen
Spain
Research Site
RECRUITING
Barcelona
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-01-26
Estimated Completion Date: 2031-11-30
Participants
Target number of participants: 3195
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: IQVIA Pty Ltd