Anifrolumab Malignancy and Serious Infections Study (NCT07000110) | Clinical Trial Compass
RecruitingNot Applicable
Anifrolumab Malignancy and Serious Infections Study
Denmark, France, Germany3,506 participantsStarted 2026-01-26
Plain-language 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.
Who can participate
Age range
18 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically tracking malignancies and serious infections in people taking anifrolumab for lupus, does my personal medical history — like any past infections or cancer — make these risks something I should be especially concerned about?
2This trial appears to be an observational safety study rather than a treatment trial — does that mean I would just be monitored while continuing my current lupus treatment, and what would that monitoring actually involve in my day-to-day life?
3Given that the study is measuring infection-related hospitalizations and deaths as primary outcomes, how does the safety profile of anifrolumab compare to the lupus treatments I'm already on or being considered for?
4Are there standard lupus treatments available right now that have a longer or more established safety record than what's being studied here, and would trying those first make more sense for my situation?
5If I enroll and the monitoring detects a serious infection or another safety concern during the study, what happens next — would I be taken off anifrolumab, and who would manage that process?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.