Status:
NOT_YET_RECRUITING
Anifrolumab Malignancy and Serious Infections Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Iqvia Pty Ltd
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-130 years
Brief 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 w...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 28 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2031
Estimated Enrollment :
3506 Patients enrolled
Trial Details
Trial ID
NCT07000110
Start Date
November 28 2025
End Date
November 30 2031
Last Update
August 15 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.