No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 130
Sex
Any
Study type
Observational
Participants needed
125 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for adults with systemic lupus erythematosus who are starting treatment with subcutaneous anifrolumab. Participants will take part in evaluations and provide feedback about their experience over 24 months.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with systemic lupus erythematosus.
I have been prescribed subcutaneous anifrolumab.
The decision to start anifrolumab was made before this study.
I have signed the consent form to join the study.
I am willing to participate in all study evaluations.
You may not be able to join if
I have used anifrolumab before.
I am currently taking other biologic treatments.
I am participating in another clinical study.
I have severe kidney issues that need urgent treatment.
I have severe mental health issues that affect my participation.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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City
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Status
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 d…
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
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