이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 9월 21일 업데이트: AstraZeneca

ASTER: 실제 세계에서 치료 효과에 대한 아니프로루맙 연구 일상적인 임상 실습에서 아니프로루맙을 받는 SLE 환자를 대상으로 한 다국적, 관찰, 출시 후 유효성 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study.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

연구 유형

관찰

등록 (실제)

551

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.
다른: None (Observational study)

Not Applicable since Observational Study

다른 이름들:
  • 관찰 연구

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Disease activity assessed by the Physician Global Assessment (PGA)
기간: 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)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Proportion of patients attaining Definition of Remission in SLE (DORIS)
기간: 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)
기간: 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).
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AstraZeneca

협력자

Parexel

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 2월 27일

기본 완료 (추정된)

2030년 12월 30일

연구 완료 (추정된)

2030년 12월 30일

연구 등록 날짜

최초 제출

2022년 11월 24일

QC 기준을 충족하는 최초 제출

2022년 11월 24일

처음 게시됨 (실제)

2022년 12월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 21일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • D3461R00043

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다