NCT07000110Recruiting
Anifrolumab Malignancy and Serious Infections Study
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
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3506 (estimated)
- First submitted
- 22 May 2025
- Start date
- 26 Jan 2026
- Primary completion date
- 30 Nov 2031
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT07000110
What you commit to
- Study type: Observational
- Planned participants: 3506
- From 26 Jan 2026 to the primary completion date, 30 Nov 2031
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| - Coordinator of this site? Confirm its status | Copenhagen | Denmark | Recruiting |
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Charenton-le-Pont | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.