ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) or any of its components at 6 months from the date of first anifrolumab infusion
研究概览
简要总结
The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.
详细描述
This is a multi-country, multi-site retrospective chart review study that will use data extracted from the medical charts of SLE patients who participated in the anifrolumab EAPs AMANA or ATUc in France, Germany, Greece, Israel, Italy, Portugal, Spain, and the UK. Patient level data will be captured longitudinally for each patient over a 12- to 18-month period. The study period will include retrospective data collection covering a minimum 6- month baseline period prior to the index date and retrospective data collection covering a minimum 6-month FU period from the first Anifrolumab infusion. The index date is defined as the date of first anifrolumab infusion during the indexing period. The indexing period is between the earliest date of patient enrolment into the EAP and the date of last new patient enrolment into EAP. The EAPs have closed by end of February 2023 in all countries included in the ERYTHRO study. One data extraction will be performed per patient.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 time of enrolment into AMANA or France ATUc program, and
- •Have at least 6 months of data from medical charts available prior to the initiation of anifrolumab through the EAP, and
- •Have been initiated on anifrolumab at least 6 months before enrolment into ERYTHRO study, and
- •Informed consent obtained (where required as per country regulations) to participate in ERYTHRO
排除标准
- •Participated in anifrolumab clinical trials, NCT02794285 (D3461C00009) and / or NCT01753193 (D3461C00003), prior to enrolment into AMANA or France ATUc program, or
- •Participated in any SLE clinical trial during the baseline period and / or the FU period of ERYTHRO, or
- •Patients who were pregnant during the baseline period and / or the FU period of ERYTHRO
结局指标
主要结局
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) or any of its components at 6 months from the date of first anifrolumab infusion
时间窗: 6-month longitudinal data capture
The SLEDAI-2K stands for Systemic Lupus Erythematosus Disease Activity Index -2000. It measures disease activity in the 28 days prior to and at the time point of the assessment. It 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 (anti-dsDNA positive or negative) 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. In practice it is expected that SLEDAI scores will be skewed towards 0, with scores higher than 20 being rare.
Disease activity assessed by the Physician Global Assessment (PGA) at 6 months from the date of first anifrolumab infusion
时间窗: 6-month longitudinal data capture
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). 0 - none 1. - mild 2. - moderate 3. - severe
次要结局
- 4. The extent of skin manifestations over time as described by Cutaneous LE Disease Area and Severity Index (CLASI) during baseline and at 6 months after the data of first anifrolumab infusion(6-month longitudinal data capture)
- 10. SLE related tests performed during baseline and FU, respectively(12- to 18-month longitudinal data capture)
- 1. Proportion of patients achieving SLE remission at 6 months from the date of first anifrolumab infusion(6-month longitudinal data capture)
- 3. The frequency overall and by intensity (mild / moderate and severe) of flares as assessed by the Revised Safety of Estrogens in Lupus National Assessment - SLE Disease Activity Index Flare Index (rSFI) at baseline and during follow up.(6-month longitudinal data capture)
- 2. Proportion of patients achieving all four criteria for low disease activity (LLDAS) at 6 months from first anifrolumab infusion(6-month longitudinal data capture)
- 5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)(12- to 18-month longitudinal data capture)
- 6. Usage of anifrolumab, including adherence(12- to 18-month longitudinal data capture)
- 8. Baseline patient characteristics(12- to 18-month longitudinal data capture)
- 9. Describe baseline comorbidities described by Charlson Comorbidity Index (CCI) or any of its components(12- to 18-month longitudinal data capture)
- 11. SLE related tests performed during baseline and FU, respectively(12- to 18-month longitudinal data capture)
- 7. Usage of anifrolumab, including persistence(12- to 18-month longitudinal data capture)
- 12. SLE related tests performed during baseline and FU, respectively(12- to 18-month longitudinal data capture)
- 13. SLE related tests performed during baseline and FU, respectively(12- to 18-month longitudinal data capture)