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โ† Trials
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NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Recruitingn/aAges 18 Years - 130 YearsAllAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years at the time of signing the informed consent * Diagnosis of SLE * Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC) * Prescription of anifrolumab SC was decided prior to and independently of the study * Signed and dated written informed consent prior to enrolment into the study * Willing and able to participate in all study evaluations and procedures Exclusion Criteria: * Prior exposure to anifrolumab * Treatment with concurrent biologics * Current or planned participation in a clinical study that does not constitute routine care * Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus * Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits) * Pregnancy or breast feeding at study enrolment
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What it tests

  • Not listed
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Where

21 sites
Research Site
Altenburg, Germany
Research Site
Bad Bramstedt, Germany
Research Site
Bamberg, Germany
Research Site
Berlin, Germany
Research Site
Braunschweig, Germany
Research Site
Chemnitz, Germany
Research Site
Erlangen, Germany
Research Site
Hanover, Germany

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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