Actively Recruiting
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
Led by AstraZeneca · Updated on 2026-05-12
125
Participants Needed
16
Research Sites
180 weeks
Total Duration
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AI-Summary
What this Trial Is About
VIOLET is a prospective, single-arm, multi-centre, non-interventional study (NIS) evaluating real-world clinical and patient-reported outcome (PRO) data in adult patients who are initiated on subcutaneous anifrolumab treatment of systemic lupus erythematosus (SLE) in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab subcutaneous (SC) or intravenous (IV) before.
CONDITIONS
Official Title
NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Diagnosis of systemic lupus erythematosus (SLE)
- Prescription of subcutaneous anifrolumab following European prescribing guidelines
- Decision to use anifrolumab SC made before and independently of the study
- Signed and dated informed consent before joining the study
- Willing and able to participate in all study procedures and evaluations
You will not qualify if you...
- Previous treatment with anifrolumab
- Use of other biologic treatments at the same time
- Current or planned participation in another clinical study not part of routine care
- Severe or rapidly progressing Class III or IV glomerulonephritis requiring induction therapy
- Isolated Class V lupus nephritis without other SLE symptoms
- Active severe or unstable neuropsychiatric lupus
- Conditions or events limiting ability to complete questionnaires or participate for 24 months (e.g., significant cognitive impairment, severe psychiatric illness, uncontrolled substance use)
- Pregnancy or breastfeeding at study enrollment
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Research Site
Altenburg, Germany
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2
Research Site
Bad Bramstedt, Germany
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3
Research Site
Berlin, Germany
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4
Research Site
Chemnitz, Germany
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5
Research Site
Erlangen, Germany
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6
Research Site
Heidelberg, Germany
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7
Research Site
Herne, Germany
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8
Research Site
Kassel, Germany
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9
Research Site
Leipzig, Germany
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10
Research Site
Meerbusch-Lank, Germany
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11
Research Site
München, Germany
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12
Research Site
Planegg, Germany
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13
Research Site
Schwerin, Germany
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14
Research Site
Trier, Germany
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15
Research Site
Wetzlar, Germany
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16
Research Site
Wuppertal, Germany
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Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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