NCT07424261 NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
| NCT ID | NCT07424261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Lupus Erythematosus, Systemic |
| Study Type | OBSERVATIONAL |
| Enrollment | 125 participants |
| Start Date | 2026-03-19 |
| Primary Completion | 2029-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 125 participants in total. It began in 2026-03-19 with a primary completion date of 2029-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07424261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying Lupus Erythematosus, Systemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07424261 currently recruiting?
Yes, NCT07424261 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07424261 trial being conducted?
This trial is being conducted at Altenburg, Germany, Bad Bramstedt, Germany, Bamberg, Germany, Berlin, Germany and 11 additional locations.
Who is sponsoring the NCT07424261 clinical trial?
NCT07424261 is sponsored by AstraZeneca. The trial plans to enroll 125 participants.
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