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

Systemic Lupus Erythematosus Clinical Trial

— ASTER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637112
• Other study ID #: D3461R00043
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: March 15, 2029

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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follow-up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 15, 2029
• Est. primary completion date: March 15, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• None (Observational study)
Not Applicable since Observational Study

Locations

Country	Name	City	State
Austria	Research Site	Graz	Styria
Austria	Research Site	Innsbruck	Tirol
Austria	Research Site	Linz	Upper Austria
Austria	Research Site	Vienna
Austria	Research Site	Vienna
Belgium	Research Site	Aalst	Oost Vlaanderen
Belgium	Research Site	Brugge	West Flanders
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Orillia	Ontario
Canada	Research Site	Rimouski	Quebec
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Ste Foy	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Winnipeg	Manitoba
Denmark	Research Site	Aalborg	North Denmark
Denmark	Research Site	Aarhus N	Central Denmark Region
Denmark	Research Site	Copenhagen	Capital Region
France	Research Site	Bordeaux Cedex	Gironde
France	Research Site	Bouches Du Rhone	Lyon
France	Research Site	Clermont Ferrand	Auvergne Rhone Alpes
France	Research Site	DIJON Cedex	Cote dOr
France	Research Site	Finistere	Brest Cedex
France	Research Site	FORT DE France Cedex	Martinique
France	Research Site	Grenoble	Isere
France	Research Site	Lille Cedex	Nord
France	Research Site	Nantes	Loire Atlantique
France	Research Site	Nice Cedex	Alpes Maritimes
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Saint Denis	La Reunion
France	Research Site	Seine Maritime	Rouen
France	Research Site	Strasbourg	Bas Rhin
Germany	Research Site	Bad Bramstedt	Hamburg
Germany	Research Site	Berlin
Germany	Research Site	Dusseldorf	North Rhine Westphalia
Germany	Research Site	Erfurt	Thuringia
Germany	Research Site	Erlangen	Bayern
Germany	Research Site	Greifswald	Mecklenburg Vorpommern
Germany	Research Site	Greifwald	Vorpommern Greifswald
Germany	Research Site	Heidelberg	Baden Wuerttemberg
Germany	Research Site	Heidelberg	Baden Wurttemberg
Germany	Research Site	Herne	North Rhine Westphalia
Germany	Research Site	Koln	North Rhine Westphalia
Germany	Research Site	Koln	Nordrhein Westfalen
Germany	Research Site	Magdeburg	Sachsen Anhalt
Germany	Research Site	Mainz A Rhein	Rheinland Pfalz
Germany	Research Site	Munich	Monachium
Germany	Research Site	Planegg	Monachium
Germany	Research Site	Schleswig Holstein	Lubeck
Israel	Research Site	Afula	Northern District
Israel	Research Site	Beersheba	HaDarom
Israel	Research Site	Haifa	Haifa District
Israel	Research Site	Haifa	Haifa District
Israel	Research Site	Jerusalem	Yerushalayim
Israel	Research Site	Kfar Saba	HaMerkaz
Israel	Research Site	Ramat Gan	Tel Aviv District
Israel	Research Site	Tel Aviv	Tel Aviv District
Israel	Research Site	Tel Hashomer	HaMerkaz
Israel	Research Site	Tiberias	Galilee
Italy	Research Site	Ancona
Italy	Research Site	Bari
Italy	Research Site	Brescia	Lombardia
Italy	Research Site	Cagliari	Sardegna
Italy	Research Site	Cona	Emilia Romagna
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Milano	Lombardia
Italy	Research Site	Napoli	Campania
Italy	Research Site	Pisa
Italy	Research Site	Roma
Italy	Research Site	Roma
Italy	Research Site	Roma	Lazio
Italy	Research Site	Torino	Piemonte
Italy	Research Site	Udine	Friuli Venezia Giulia
Sweden	Research Site	Danderyd	Stockholm
Sweden	Research Site	Orebro	Narke
Sweden	Research Site	Stockholm	Uppland
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Dubai	Dubayy
United Arab Emirates	Research Site	Dubai	Dubayy
United Arab Emirates	Research Site	Sharjah	Ash Shariqah

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Denmark,  France,  Germany,  Israel,  Italy,  Sweden,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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