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Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
Led by AstraZeneca · Updated on 2026-05-13
100
Participants Needed
11
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are observing patients with systemic lupus erythematosus (SLE) who receive anifrolumab treatment as part of routine medical care in Poland. The study aims to gather detailed information about patient characteristics and how well anifrolumab works in real-world settings. This multicenter, non-interventional study is supported by AstraZeneca and follows patients over time to understand treatment outcomes. Participants receive anifrolumab 300 mg as an infusion within the National Drug Program (NDP) in Poland. The study includes about 6 months of baseline data collection followed by approximately 24 months of follow-up. During this time, no additional treatments are assigned by the study since it is observational, focusing on patients already receiving anifrolumab. Throughout the study, researchers will collect data on disease activity using the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at multiple points, especially at 12 months. Other assessments include physician global evaluations, medication usage, corticosteroid doses, and treatment adherence every six months. The total participation can last up to 30 months, allowing for long-term monitoring of treatment effects and patient health.
CONDITIONS
Brief Title
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (aged 2518 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).
You will not qualify if you...
- Patients who participated in anifrolumab clinical trials in the past, or who plan to participate in any anifrolumab clinical trial on or after the first infusion through NDP.
- Cognitive incapacity, unwillingness, or language barriers that prevent adequate understanding or cooperation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 months
Participants who receive anifrolumab through routine clinical practice are observed to collect data on their disease activity and treatment outcomes.
Visits approximately every 6 months for assessments
Trial Site Locations
Total: 11 locations
1
Research Site
Bydgoszcz, Poland
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2
Research Site
Bytom, Poland
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3
Research Site
Gdansk, Poland
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4
Research Site
Katowice, Poland
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5
Research Site
Krakow, Poland
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6
Research Site
Lodz, Poland
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7
Research Site
Lublin, Poland
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8
Research Site
Poznan, Poland
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9
Research Site
Rzeszów, Poland
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10
Research Site
Warsaw, Poland
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11
Research Site
Wroclaw, Poland
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Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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