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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 125
- 试验地点
- 19
- 主要终点
- Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Proportion and number of patients who fulfill criteria for definition of remission in SLE (DORIS remission)
时间窗: At month 24
To assess disease activity at month 24 by evaluating the attainment of DORIS remission following initiation of anifrolumab SC treatment
次要结局
- Proportion and number of patients in DORIS remission(During routine visits up to 24 months)
- Proportion and number of patients who ever achieved DORIS remission(During routine visits up to 24 months)
- Time (in months) to first DORIS remission among patients achieving DORIS criteria(Baseline up to 24 months)
- Time (in months) spent in DORIS remission among patients achieving DORIS criteria(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(Up to 24 months)
- Proportion and number of patients attaining sustained DORIS remission among patients achieving DORIS criteria(At month 6 and month 12)
- Proportion and number of patients who fulfill criteria of lupus low disease activity state (LLDAS)(At month 24)
- Proportion and number of patients ever achieving LLDAS criteria(During routine visits up to 24 months)
- Time (in months) to first achieving LLDAS criteria among patients achieving LLDAS criteria(Up to 24 months)
- Time (in months) spent in LLDAS among patients achieving LLDAS criteria(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(Up to 24 months)
- Proportion and number of patients attaining sustained LLDAS(At month 6 and month 12)
- Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2k)(From Baseline to every routine visit up to 24 months during routine visits)
- Change in Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS)(From Baseline to every routine visit up to 24 months during routine visits)
- Change in Physician Global Assessment (PhGA) analog scale (0-3)(From Baseline to every routine visit up to 24 months during routine visits)
- Change in Systemic Lupus International Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index (SDI) score(Baseline up to month 24)
- SLE treatment patterns prior to, concomitant with and after anifrolumab(From Baseline (1 year pre-anifrolumab) up to 24 months)
- Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)(Baseline up to 24 months)
- Patient Global Assessment (PtGA)(Baseline up to 24 months)
- Lupus Quality of Life (LupusQoL)(Baseline up to 24 months)
- SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)(Baseline up to 24 months)