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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Other: None (Observational study)

Detailed Description

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 3 years of follow-up data.

The minimum enrolment period is anticipated to be 18 months per country and will 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). Relevant clinical and patient-reported outcome (PRO) data collection for the entire follow-up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study.

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Austria
  • Vienna, Austria, 1140
    • Withdrawn
    • Research Site
  • Vienna, Austria, 1180
    • Recruiting
    • Research Site
  • Styria
    • Graz, Styria, Austria, 8036
      • Withdrawn
      • Research Site
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Research Site
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Research Site
• Belgium
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • Research Site
  • Liege, Belgium, 4000
    • Not yet recruiting
    • Research Site
  • Oost Vlaanderen
    • Aalst, Oost Vlaanderen, Belgium, 9300
      • Not yet recruiting
      • Research Site
  • West Flanders
    • Brugge, West Flanders, Belgium, 8000
      • Not yet recruiting
      • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Recruiting
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, RR149
      • Not yet recruiting
      • Research Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5T 2S9
      • Recruiting
      • Research Site
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Recruiting
      • Research Site
    • Sherbrooke, Quebec, Canada, J1G 2E8
      • Recruiting
      • Research Site
    • Ste Foy, Quebec, Canada, G1V 4G2
      • Recruiting
      • Research Site
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Withdrawn
      • Research Site
  • Central Denmark Region
    • Aarhus N, Central Denmark Region, Denmark, 8200
      • Withdrawn
      • Research Site
  • North Denmark
    • Aalborg, North Denmark, Denmark, 9000
      • Withdrawn
      • Research Site
• France
  • Paris, France, 75014
    • Recruiting
    • Research Site
  • Paris, France, 75020
    • Recruiting
    • Research Site
  • Paris, France, 75013
    • Recruiting
    • Research Site
  • Paris, France, 75475
    • Recruiting
    • Research Site
  • Paris, France, 14033
    • Recruiting
    • Research Site
  • Alpes Maritimes
    • Nice Cedex, Alpes Maritimes, France, 6000
      • Recruiting
      • Research Site
  • Auvergne Rhone Alpes
    • Clermont Ferrand, Auvergne Rhone Alpes, France, 63000
      • Recruiting
      • Research Site
  • Bas Rhin
    • Strasbourg, Bas Rhin, France, 67098
      • Recruiting
      • Research Site
  • Brest Cedex
    • Finistere, Brest Cedex, France, 29609
      • Recruiting
      • Research Site
  • Cote dOr
    • DIJON Cedex, Cote dOr, France, 21079
      • Recruiting
      • Research Site
  • Gironde
    • Bordeaux Cedex, Gironde, France, 33076
      • Recruiting
      • Research Site
  • Isere
    • Grenoble, Isere, France, 38043
      • Recruiting
      • Research Site
  • La Reunion
    • Saint Denis, La Reunion, France, 97405
      • Recruiting
      • Research Site
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44093
      • Recruiting
      • Research Site
  • Lyon
    • Bouches Du Rhone, Lyon, France, 69003
      • Recruiting
      • Research Site
  • Martinique
    • FORT DE France Cedex, Martinique, France, 97261
      • Recruiting
      • Research Site
  • Nord
    • Lille Cedex, Nord, France, 59037
      • Recruiting
      • Research Site
  • Rouen
    • Seine Maritime, Rouen, France, 76230
      • Recruiting
      • Research Site
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Research Site
  • Baden Wuerttemberg
    • Heidelberg, Baden Wuerttemberg, Germany, 69120
      • Recruiting
      • Research Site
  • Baden Wurttemberg
    • Heidelberg, Baden Wurttemberg, Germany, 69120
      • Not yet recruiting
      • Research Site
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Recruiting
      • Research Site
  • Hamburg
    • Bad Bramstedt, Hamburg, Germany, 24576
      • Recruiting
      • Research Site
  • Lubeck
    • Schleswig Holstein, Lubeck, Germany, 23562
      • Recruiting
      • Research Site
  • Mecklenburg Vorpommern
    • Greifswald, Mecklenburg Vorpommern, Germany, 17493
      • Recruiting
      • Research Site
  • Monachium
    • Munich, Monachium, Germany, 81925
      • Recruiting
      • Research Site
    • Planegg, Monachium, Germany, 82152
      • Withdrawn
      • Research Site
  • Nordrhein Westfalen
    • Koln, Nordrhein Westfalen, Germany, 51149
      • Recruiting
      • Research Site
  • North Rhine Westphalia
    • Dusseldorf, North Rhine Westphalia, Germany, 40225
      • Recruiting
      • Research Site
    • Herne, North Rhine Westphalia, Germany, 44649
      • Recruiting
      • Research Site
    • Koln, North Rhine Westphalia, Germany, 30625
      • Withdrawn
      • Research Site
  • Rheinland Pfalz
    • Mainz A Rhein, Rheinland Pfalz, Germany, 55131
      • Recruiting
      • Research Site
  • Sachsen Anhalt
    • Magdeburg, Sachsen Anhalt, Germany, 39104
      • Recruiting
      • Research Site
  • Thuringia
    • Erfurt, Thuringia, Germany, 99096
      • Withdrawn
      • Research Site
  • Vorpommern Greifswald
    • Greifwald, Vorpommern Greifswald, Germany, 17489
      • Recruiting
      • Research Site
• Israel
  • Galilee
    • Tiberias, Galilee, Israel, 15208
      • Recruiting
      • Research Site
  • HaDarom
    • Beersheba, HaDarom, Israel, 8410101
      • Not yet recruiting
      • Research Site
  • HaMerkaz
    • Kfar Saba, HaMerkaz, Israel, 4428164
      • Recruiting
      • Research Site
    • Tel Hashomer, HaMerkaz, Israel, 5211401
      • Recruiting
      • Research Site
  • Haifa District
    • Haifa, Haifa District, Israel, 3109601
      • Recruiting
      • Research Site
    • Haifa, Haifa District, Israel, 3436212
      • Recruiting
      • Research Site
  • Northern District
    • Afula, Northern District, Israel, 18101
      • Not yet recruiting
      • Research Site
  • Tel Aviv District
    • Ramat Gan, Tel Aviv District, Israel, 52621
      • Recruiting
      • Research Site
    • Tel Aviv, Tel Aviv District, Israel, 6423906
      • Recruiting
      • Research Site
  • Yerushalayim
    • Jerusalem, Yerushalayim, Israel, 91120
      • Not yet recruiting
      • Research Site
• Italy
  • Ancona, Italy, 60126
    • Not yet recruiting
    • Research Site
  • Bari, Italy, 70124
    • Not yet recruiting
    • Research Site
  • Firenze, Italy, 50134
    • Recruiting
    • Research Site
  • Milano, Italy, 20132
    • Not yet recruiting
    • Research Site
  • Milano, Italy, 20122
    • Recruiting
    • Research Site
  • Pisa, Italy, 56126
    • Recruiting
    • Research Site
  • Roma, Italy, 168
    • Recruiting
    • Research Site
  • Roma, Italy, 161
    • Not yet recruiting
    • Research Site
  • Campania
    • Napoli, Campania, Italy, 80131
      • Not yet recruiting
      • Research Site
  • Emilia Romagna
    • Cona, Emilia Romagna, Italy, 44124
      • Recruiting
      • Research Site
  • Friuli Venezia Giulia
    • Udine, Friuli Venezia Giulia, Italy, 33100
      • Recruiting
      • Research Site
  • Lazio
    • Roma, Lazio, Italy, 149
      • Not yet recruiting
      • Research Site
  • Lombardia
    • Brescia, Lombardia, Italy, 25100
      • Recruiting
      • Research Site
    • Milano, Lombardia, Italy, 20122
      • Recruiting
      • Research Site
  • Piemonte
    • Torino, Piemonte, Italy, 10126
      • Recruiting
      • Research Site
  • Sardegna
    • Cagliari, Sardegna, Italy, 9042
      • Not yet recruiting
      • Research Site
• Sweden
  • Narke
    • Orebro, Narke, Sweden, 70185
      • Recruiting
      • Research Site
  • Stockholm
    • Danderyd, Stockholm, Sweden, 18288
      • Recruiting
      • Research Site
  • Uppland
    • Stockholm, Uppland, Sweden, 171 76
      • Recruiting
      • Research Site
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Not yet recruiting
    • Research Site
  • Ash Shariqah
    • Sharjah, Ash Shariqah, United Arab Emirates, 72772
      • Not yet recruiting
      • Research Site
  • Dubayy
    • Dubai, Dubayy, United Arab Emirates, 7272
      • Not yet recruiting
      • Research Site
    • Dubai, Dubayy, United Arab Emirates
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.
• It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.
• In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (i.e. 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.
• Previous exposure to anifrolumab as part of a clinical trial or early access program.
• 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, 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 or complete the PROs.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: None (Observational study); Not Applicable since Observational Study; Other Names: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity assessed by the Physician Global Assessment (PGA)	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 3 years post-anifrolumab initiation
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)	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 3 years post-anifrolumab initiation
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)	The proportion of patients attaining the composite endpoint of LLDAS will be assesed.	From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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 3 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).	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 3 years post-anifrolumab initiation
SLE treatment patterns prior to, concomitant with and after anifrolumab	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 3 years post-anifrolumab initiation
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)	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)	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)	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)	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)	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)	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	The healthcare resource utilization (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 3 years post-anifrolumab initiation
Number of hospital admissions and inpatient hospital procedures	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 3 years post-anifrolumab initiation
Number of rheumatologist visits and procedures	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 3 years post-anifrolumab initiation
Number of dialysis appointments	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 3 years post-anifrolumab initiation

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 15, 2029

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: corticosteroids; Real World; immunosuppressants; chronic autoimmune disease; human monoclonal antibody (IgG1ƙ mAb)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: D3461R00043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame: 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 Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No