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NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Lupus Erythematosus, Systemic

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥18 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

Locations (16)

Altenburg, Germany
Bad Bramstedt, Germany
Berlin, Germany
Chemnitz, Germany
Erlangen, Germany
Heidelberg, Germany
Herne, Germany
Kassel, Germany
Leipzig, Germany
Meerbusch-Lank, Germany
München, Germany
Planegg, Germany
Schwerin, Germany
Trier, Germany
Wetzlar, Germany
Wuppertal, Germany