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

Официальное название

Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematodes - A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care

Обзор

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.

Подробное описание

This is a prospective, single-arm, multicenter, non-interventional study (NIS) to evaluate real-world clinical and patient-reported outcomes in adult patients with SLE who are initiated on anifrolumab SC therapy in line with the applicable european summary of product characteristics (SmPC) and neither having used anifrolumab SC or IV before.

This study aims to describe disease activity of SLE assessed by key treatment goals remission (DORIS) and lupus low disease activity (LLDAS), patient-reported quality of life, patterns of concomitant medication, and clinically relevant outcomes such as flares and organ damage in SLE patients treated with anifrolumab SC in a real-life setting. The 24-month observation period is chosen to capture long-term disease activity and disease control, and evaluate concomitant medication, and organ damage accrual in routine care.

Первичные конечные точки

• Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission) [Срок оценки: At month 24]

Вторичные конечные точки (12)

• Proportion and number of patients in DORIS remission [Срок оценки: During routine visits up to 24 months]
• Proportion and number of patients who ever achieved DORIS remission [Срок оценки: During routine visits up to 24 months]
• Time (in months) to first DORIS remission among patients achieving DORIS criteria [Срок оценки: Baseline up to 24 months]
• Time (in months) spent in DORIS remission among patients achieving DORIS criteria [Срок оценки: Up to 24 months]
• Time (in months) spent in sustained DORIS remission if in remission for at least 2 consecutive routine visits among patients achieving DORIS criteria [Срок оценки: Up to 24 months]
• Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria [Срок оценки: At month 6 and month 12]
• Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS) [Срок оценки: At month 24]
• Proportion and number of patients ever achieving LLDAS criteria [Срок оценки: During routine visits up to 24 months]
• Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria [Срок оценки: Up to 24 months]
• Time (in months) spent in LLDAS among patients achieving LLDAS criteria [Срок оценки: Up to 24 months]
• Time (in months) spent in sustained LLDAS if in LLDAS for at least 2 consecutive routine visits among patients achieving LLDAS criteria [Срок оценки: Up to 24 months]
• Proportion and number of patients attaining sustained LLDAS [Срок оценки: At month 6 and month 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 16 центров

• Research Site — Altenburg
• Research Site — Bad Bramstedt
• Research Site — Berlin
• Research Site — Chemnitz
• Research Site — Erlangen
• Research Site — Heidelberg
• Research Site — Herne
• Research Site — Kassel
• … и ещё 8 центров

Идентификаторы

NCT: NCT07424261 · D3461R00100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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