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A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice. (ASTER)

2026年9月21日 更新者：AstraZeneca

ASTER: Anifrolumab による実世界での治療効果に関する研究ルーチンの臨床診療で Anifrolumab を投与されている SLE 患者を対象とした多国籍、観察、上市後の有効性研究

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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

詳細な説明

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continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study.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.

Electronic data collection will be the only method of data collection in this study.

研究の種類

観察的

入学 (実際)

551

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アラブ首長国連邦
      • Abu Dhabi、アラブ首長国連邦
        • Research Site
    • Dubayy
      • Dubai、Dubayy、アラブ首長国連邦、7272
        • Research Site
    • Emirate of Sharjah
      • Sharjah city、Emirate of Sharjah、アラブ首長国連邦、72772
        • Research Site
  • イスラエル
    • Central District
      • Kfar Saba、Central District、イスラエル、4428164
        • Research Site
      • Tel Hashomer、Central District、イスラエル、5211401
        • Research Site
    • Galilee
      • Tiberias、Galilee、イスラエル、15208
        • Research Site
    • Haifa District
      • Haifa、Haifa District、イスラエル、3109601
        • Research Site
      • Haifa、Haifa District、イスラエル、3436212
        • Research Site
    • Jerusalem
      • Jerusalem、Jerusalem、イスラエル、91120
        • Research Site
    • Northern District
      • Afula、Northern District、イスラエル、18101
        • Research Site
    • Tel Aviv
      • Ramat Gan、Tel Aviv、イスラエル、52621
        • Research Site
      • Tel Aviv、Tel Aviv、イスラエル、6423906
        • Research Site
  • イタリア
      • Ancona、イタリア、60126
        • Research Site
      • Bari、イタリア、70124
        • Research Site
      • Florence、イタリア、50134
        • Research Site
      • Milan、イタリア、20122
        • Research Site
      • Milan、イタリア、20132
        • Research Site
      • Pisa、イタリア、56126
        • Research Site
      • Roma、イタリア、168
        • Research Site
      • Roma、イタリア、161
        • Research Site
    • Campania
      • Naples、Campania、イタリア、80131
        • Research Site
    • Emilia-Romagna
      • Cona、Emilia-Romagna、イタリア、44124
        • Research Site
    • Friuli Venezia Giulia
      • Udine、Friuli Venezia Giulia、イタリア、33100
        • Research Site
    • Lazio
      • Rome、Lazio、イタリア、149
        • Research Site
    • Lombardy
      • Brescia、Lombardy、イタリア、25100
        • Research Site
      • Milan、Lombardy、イタリア、20122
        • Research Site
    • Piedmont
      • Turin、Piedmont、イタリア、10126
        • Research Site
    • Sardinia
      • Cagliari、Sardinia、イタリア、9042
        • Research Site
  • オーストリア
      • Vienna、オーストリア、1180
        • Research Site
    • Tyrol
      • Innsbruck、Tyrol、オーストリア、6020
        • Research Site
    • Upper Austria
      • Linz、Upper Austria、オーストリア、4020
        • Research Site
  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 4N1
        • Research Site
    • Manitoba
      • Winnipeg、Manitoba、カナダ、RR149
        • Research Site
    • Ontario
      • Hamilton、Ontario、カナダ、L8N 3Z5
        • Research Site
      • Orillia、Ontario、カナダ、L3V 1T5
        • Research Site
      • Toronto、Ontario、カナダ、M5T 2S9
        • Research Site
    • Quebec
      • Rimouski、Quebec、カナダ、G5L 5T1
        • Research Site
      • Sherbrooke、Quebec、カナダ、J1G 2E8
        • Research Site
      • Ste-Foy、Quebec、カナダ、G1V 4G2
        • Research Site
  • スウェーデン
    • N Rke
      • Örebro、N Rke、スウェーデン、70185
        • Research Site
    • Uppland
      • Stockholm、Uppland、スウェーデン、171 76
        • Research Site
  • ドイツ
      • Berlin、ドイツ、10117
        • Research Site
    • Baden-W Rttemberg
      • Heidelberg、Baden-W Rttemberg、ドイツ、69120
        • Research Site
    • Baden-Wurttemberg
      • Heidelberg、Baden-Wurttemberg、ドイツ、69120
        • Research Site
    • Bavaria
      • Erlangen、Bavaria、ドイツ、91054
        • Research Site
    • Free and Hanseatic City of Hamburg
      • Bad Bramstedt、Free and Hanseatic City of Hamburg、ドイツ、24576
        • Research Site
    • L Beck
      • Schleswig-Holstein、L Beck、ドイツ、23562
        • Research Site
    • Mecklenburg-Vorpommern
      • Greifswald、Mecklenburg-Vorpommern、ドイツ、17493
        • Research Site
    • North Rhine-Westphalia
      • Cologne、North Rhine-Westphalia、ドイツ、51149
        • Research Site
      • D Sseldorf、North Rhine-Westphalia、ドイツ、40225
        • Research Site
      • Herne、North Rhine-Westphalia、ドイツ、44649
        • Research Site
    • Rhineland-Palatinate
      • Mainz A. Rhein、Rhineland-Palatinate、ドイツ、55131
        • Research Site
    • Saxony-Anhalt
      • Magdeburg、Saxony-Anhalt、ドイツ、39104
        • Research Site
    • Vorpommern-Greifswald
      • Greifwald、Vorpommern-Greifswald、ドイツ、17489
        • Research Site
  • フランス
      • Paris、フランス、75020
        • Research Site
      • Paris、フランス、75014
        • Research Site
      • Paris、フランス、75013
        • Research Site
      • Paris、フランス、75475
        • Research Site
      • Paris、フランス、14033
        • Research Site
    • Alpes-Maritimes
      • Nice、Alpes-Maritimes、フランス、6000
        • Research Site
    • Auvergne-Rh ne-Alpes
      • Clermont-Ferrand、Auvergne-Rh ne-Alpes、フランス、63000
        • Research Site
    • Bas-Rhin
      • Strasbourg、Bas-Rhin、フランス、67098
        • Research Site
    • Brest Cedex
      • Finist Re、Brest Cedex、フランス、29609
        • Research Site
    • C te-d'Or
      • Dijon、C te-d'Or、フランス、21079
        • Research Site
    • Gironde
      • Bordeaux、Gironde、フランス、33076
        • Research Site
    • Is Re
      • Grenoble、Is Re、フランス、38043
        • Research Site
    • La R Union
      • Saint-Denis、La R Union、フランス、97405
        • Research Site
    • Loire-Atlantique
      • Nantes、Loire-Atlantique、フランス、44093
        • Research Site
    • Lyon
      • Bouches-du-Rh Ne、Lyon、フランス、69003
        • Research Site
    • Martinique
      • FORT de France Cedex、Martinique、フランス、97261
        • Research Site
    • Nord
      • Lille、Nord、フランス、59037
        • Research Site
    • Rouen
      • Seine-Maritime、Rouen、フランス、76230
        • Research Site
  • ベルギー
      • Leuven、ベルギー、3000
        • Research Site
    • Li Ge
      • Liège、Li Ge、ベルギー、4000
        • Research Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～130年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

コホートと介入

グループ/コホート
介入・治療
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.
他の：None (Observational study)

Not Applicable since Observational Study

他の名前：
  • 観察研究

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Disease activity assessed by the Physician Global Assessment (PGA)
時間枠：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).
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
時間枠：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.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
時間枠：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.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients attaining Definition of Remission in SLE (DORIS)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The proportion of patients attaining the Definition of Remission in SLE will be assesed.
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)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

Flare will be defined as any one criterion present either the Mild/Moderate Flare or Severe Flare categories. New or worsened manifestation will only be reported for manifestation of SLE.
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).
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index will be assessed. The irreversible, accumulated organ damage from either the disease process or disease treatment, which has been present for at least 6 months, in 12 organ systems will be measured.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
SLE treatment patterns prior to, concomitant with and after anifrolumab
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

SLE treatment patterns will be analyzed through prevalence and incidence in respect to time to discontinuation.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The FACIT-Fatigue is a 13-item questionnaire formatted for self-administration that assesses patient-reported fatigue and its impact upon daily activities and function over the past 7 days. Patients will be asked to answer each question using a 5-point verbal rating scale, with total scores ranging from 0 (most fatigued) to 52 (least fatigued).
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Lupus Quality of Life (LupusQoL)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The LupusQoL is a validated SLE-specific HRQoL (health-related quality of life) instrument consisting of 34 items across 8 domains (Physical health, Emotional health, Body image, Pain, Planning, Fatigue, Intimate relationships, and Burden to others). The LupusQoL has a 5-point verbal rating scale, and uses a 4-week recall period. The mean raw domain score is transformed to scores ranging from 25 (worst HRQoL) to 125 (best HRQoL) by dividing by 4 and then multiplying by 100.
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Patient Global Assessment (PtGA)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The PtGA is a single-item question that takes into account all the ways in which illness and health conditions may affect the patient at this time. The patient should consider the previous week when answering this question. Responses range from 0 (Very Well) to 100 (Very Poorly) on a visual analogue scale (VAS).
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The EQ-5D-5L is a general health status measure comprising a descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. Patients are asked to rate their current health and functional status on a 5-point verbal rating scale for each of the 5 domains. Responses are converted into an overall quality of life score via a preference-based statistical mapping algorithm. The scores on these 5 dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles. Additionally, patients are asked to indicate how they rate their current overall health on a visual analog scale (EQ-VAS) ranges from 100 for best imaginable health state to 0 for worst imaginable health state.
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Work Productivity and Activity Impairment - Lupus (WPAI:lupus)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The WPAI:Lupus is an SLE-specific, self-administered questionnaire, that assesses the impact of disease on productivity. The WPAI:Lupus consists of 6 items and has a recall period of the past 7 days. The WPAI:Lupus is divided into 4 domains: Absenteeism (work time missed), Presenteeism (VAS [scored from 0 to 10] rating of impairment while working), Working Productivity Loss (overall work impairment/absenteeism plus presenteeism), and Activity Impairment (VAS [scored from 0 to 10] rating of daily activity, other than work at a job). Scores for each domain are expressed as impairment percentages, with higher scores indicating greater productivity impairment.
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Pain Numerical Rating Scale (NRS)
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

The pain NRS will measure the pain severity in the past seven days on a scale of 0-10 (0: no pain; 10: worst pain imaginable).
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Number of outpatient hospital and emergency room visits and procedures
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The healthcare resource utilisation (HCRU) for SLE after anifrolumab initiation as recorded in medical records will be assessed. The 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
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The HCRU for SLE after anifrolumab initiation as recorded in medical records will be assessed. The number of hospital admissions and inpatient hospital procedures (including duration of hospital stay and reason for hospitalization, stratified by admission to an intensive care unit [ICU] vs non-ICU) will be assessed.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Number of rheumatologist visits and procedures
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The HCRU for SLE after anifrolumab initiation as recorded in medical records will be assessed. The number of rheumatologist visits and procedures (including SLE-related laboratory tests) will be assessed.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Number of dialysis appointments
時間枠：From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

The HCRU for SLE after anifrolumab initiation as recorded in medical records will be assessed. The number of dialysis appointments will be assessed.
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

AstraZeneca

協力者

Parexel

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年2月27日

一次修了 (推定)

2030年12月30日

研究の完了 (推定)

2030年12月30日

試験登録日

最初に提出

2022年11月24日

QC基準を満たした最初の提出物

2022年11月24日

最初の投稿 (実際)

2022年12月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • D3461R00043

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共有時間枠

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共有アクセス基準

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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