ASTER: Anifrolumab Study for Treatment Effectiveness in the Real World Multi-National, Observational, Post-Launch Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 551
- 试验地点
- 78
- 主要终点
- Disease activity assessed by the Physician Global Assessment (PGA)
研究概览
简要总结
Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.
详细描述
ASTER is a multi-country, single-arm, prospective, observational study. The study will be initiated on a country-by country basis following the commercial launch of anifrolumab. ASTER is a cohort study, with 1-year retrospective baseline data and up to 5 years of follow-up data.
The minimum enrolment period is anticipated to be 18 months (± 5 months) per country, but it may be extended, if necessary, to reach the overall study target.
In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Data collection will continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study. Relevant clinical data collection will continue for the entire follow up while patient reported outcome (PRO) data collection will continue only up to the 3-year follow up.
The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations.
The eCRFs will be accessed through secure web-based portals and will be used to ensure consistent data collection for each healthcare provider involved in this study.
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
- •Fulfilled the 2019 EULAR (European League Against Rheumatism)/ACR (American College of Rheumatology) criteria for SLE at the time of study entry.
- •Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
- •The Physician's decision to prescribe anifrolumab must occur prior to any study-related discussion.
- •In countries where prescription reimbursements are authorised on a case-by-case basis, authorisation (ie, patient access to treatment) will be required for study entry.
排除标准
- •Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
- •Any previous exposure to anifrolumab (including as part of a clinical trial or early access programme).
- •Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil [MMF]/cyclophosphamide [CYC] + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, ie. skin/joint involvement), or active severe or unstable neuropsychiatric lupus.
- •Any other condition which the investigator deems to limit a patient's ability to understand the informed consent.
研究组 & 干预措施
Prospective Cohort
All patients aged ≥18 years diagnosed with SLE who initiate anifrolumab as prescribed by their healthcare provider (HCP) per the approved country-specific label and are treated at the study sites will be eligible for inclusion.
干预措施: None (Observational study) (Other)
结局指标
主要结局
Disease activity assessed by the Physician Global Assessment (PGA)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The proportion of patients attaining the composite endpoint of LLDAS will be assesed.
Disease activity assessed by the Physician Global Assessment (PGA)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
时间窗: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The proportion of patients attaining the composite endpoint of LLDAS will be assesed.
次要结局
- Proportion of patients attaining Definition of Remission in SLE (DORIS)(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Clinical SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- SLE treatment patterns prior to, concomitant with and after anifrolumab(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Lupus Quality of Life (LupusQoL)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Patient Global Assessment (PtGA)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Work Productivity and Activity Impairment - Lupus (WPAI:lupus)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Pain Numerical Rating Scale (NRS)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Number of outpatient hospital and emergency room visits and procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of hospital admissions and inpatient hospital procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of rheumatologist visits and procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of dialysis appointments(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- SLE treatment patterns prior to, concomitant with and after anifrolumab(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Proportion of patients attaining Definition of Remission in SLE (DORIS)(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Clinical SLE Flares assessment by modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI)(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Lupus Quality of Life (LupusQoL)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Patient Global Assessment (PtGA)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Work Productivity and Activity Impairment - Lupus (WPAI:lupus)(From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation)
- Number of outpatient hospital and emergency room visits and procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of hospital admissions and inpatient hospital procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of rheumatologist visits and procedures(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)
- Number of dialysis appointments(From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation)