Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
Poland105 participantsStarted 2025-02-28
Plain-language summary
The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.
Who can participate
Age range
18 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
. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
. Patients willing to participate in the study and signed Informed Consent Form (ICF).
Exclusion criteria
. Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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 is a real-world observational study tracking how anifrolumab performs outside of a controlled trial setting, does the data collected here give you any additional confidence — or raise any concerns — about how well anifrolumab works for patients like me?
2The trial is measuring changes in SLEDAI-2K scores, which track lupus disease activity over time — based on what's been observed so far in studies like this, what kind of improvement in disease activity would you realistically hope to see for me on anifrolumab?
3This study is no longer actively enrolling, so I can't join it — but are there similar real-world or observational studies on anifrolumab that I could potentially participate in, or that you'd recommend I look into?
4Given that this is a Phase N/A observational study rather than a randomized controlled trial, how does it factor into your thinking about recommending anifrolumab versus other treatment options like belimumab or standard immunosuppressants for my specific case?
5Since this study is tracking patients who are already receiving anifrolumab in routine clinical care, does it tell us anything useful about how patients manage the drug's demands — like the monthly IV infusions — in day-to-day life that might affect whether it's a practical fit for me?
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.
What they're measuring
1
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score