Clinical trial NCT05637112: A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: chronic autoimmune disease
immunosuppressants
corticosteroids
human monoclonal antibody (IgG1ƙ mAb)
Real World
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Parexel
First posted: 2022-12-05
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease activity assessed by the Physician Global Assessment (PGA)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcomes:
measure: Proportion of patients attaining Definition of Remission in SLE (DORIS)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: 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)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: SLE treatment patterns prior to, concomitant with and after anifrolumab
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Lupus Quality of Life (LupusQoL)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Patient Global Assessment (PtGA)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Work Productivity and Activity Impairment - Lupus (WPAI:lupus)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Pain Numerical Rating Scale (NRS)
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Number of outpatient hospital and emergency room visits and procedures
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Number of hospital admissions and inpatient hospital procedures
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Number of rheumatologist visits and procedures
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
measure: Number of dialysis appointments
timeFrame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
state: Styria
city: Innsbruck
country: Austria
facility: Research Site
state: Tirol
city: Linz
country: Austria
facility: Research Site
state: Upper Austria
city: Vienna
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
state: Oost-Vlaanderen
city: Brugge
country: Belgium
facility: Research Site
state: West Flanders
city: Leuven
country: Belgium
facility: Research Site
city: Li Ge
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: Orillia
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Rimouski
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Ste-Foy
country: Canada
facility: Research Site
state: Quebec
city: Copenhagen
country: Denmark
facility: Research Site
state: Capital Region
city: Aarhus N
country: Denmark
facility: Research Site
state: Central Denmark Region
city: Aalborg
country: Denmark
facility: Research Site
state: North Denmark
city: Nice Cedex
country: France
facility: Research Site
state: Alpes-Maritimes
city: Clermont-Ferrand
country: France
facility: Research Site
state: Auvergne-Rh ne-Alpes
city: Strasbourg
country: France
facility: Research Site
state: Bas-Rhin
city: Finist Re
country: France
facility: Research Site
state: Brest Cedex
city: DIJON Cedex
country: France
facility: Research Site
state: C te-d'Or
city: Bordeaux Cedex
country: France
facility: Research Site
state: Gironde
city: Grenoble
country: France
facility: Research Site
state: Is Re
city: Saint Denis
country: France
facility: Research Site
state: La R Union
city: Nantes
country: France
facility: Research Site
state: Loire-Atlantique
city: Bouches-du-Rh Ne
country: France
facility: Research Site
state: Lyon
city: FORT DE France Cedex
country: France
facility: Research Site
state: Martinique
city: Lille Cedex
country: France
facility: Research Site
state: Nord
city: Seine-Maritime
country: France
facility: Research Site
state: Rouen
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
state: Baden Wuerttemberg
city: Heidelberg
country: Germany
facility: Research Site
state: Baden-W Rttemberg
city: Erlangen
country: Germany
facility: Research Site
state: Bayern
city: Bad Bramstedt
country: Germany
facility: Research Site
state: Hamburg
city: Schleswig-Holstein
country: Germany
facility: Research Site
state: L Beck
city: Greifswald
country: Germany
facility: Research Site
state: Mecklenburg-Vorpommern
city: Munich
country: Germany
facility: Research Site
state: Monachium
city: Planegg
country: Germany
facility: Research Site
state: Monachium
city: K Ln
country: Germany
facility: Research Site
state: Nordrhein-Westfalen
city: D Sseldorf
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Herne
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: K Ln
country: Germany
facility: Research Site
state: North Rhine-Westphalia
city: Mainz A. Rhein
country: Germany
facility: Research Site
state: Rheinland-Pfalz
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen-Anhalt
city: Erfurt
country: Germany
facility: Research Site
state: Thuringia
city: Greifwald
country: Germany
facility: Research Site
state: Vorpommern-Greifswald
city: Berlin
country: Germany
facility: Research Site
city: Tiberias
country: Israel
facility: Research Site
state: Galilee
city: Beersheba
country: Israel
facility: Research Site
state: HaDarom
city: Haifa
country: Israel
facility: Research Site
state: Haifa District
city: Haifa
country: Israel
facility: Research Site
state: Haifa District
city: Kfar-Saba
country: Israel
facility: Research Site
state: HaMerkaz
city: Tel Hashomer
country: Israel
facility: Research Site
state: HaMerkaz
city: Afula
country: Israel
facility: Research Site
state: Northern District
city: Ramat-Gan
country: Israel
facility: Research Site
state: Tel Aviv District
city: Tel Aviv
country: Israel
facility: Research Site
state: Tel Aviv District
city: Jerusalem
country: Israel
facility: Research Site
state: Yerushalayim
city: Napoli
country: Italy
facility: Research Site
state: Campania
city: Cona
country: Italy
facility: Research Site
state: Emilia Romagna
city: Udine
country: Italy
facility: Research Site
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Research Site
state: Lazio
city: Brescia
country: Italy
facility: Research Site
state: Lombardia
city: Milano
country: Italy
facility: Research Site
state: Lombardia
city: Torino
country: Italy
facility: Research Site
state: Piemonte
city: Cagliari
country: Italy
facility: Research Site
state: Sardegna
city: Ancona
country: Italy
facility: Research Site
city: Bari
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Orebro
country: Sweden
facility: Research Site
state: N Rke
city: Danderyd
country: Sweden
facility: Research Site
state: Stockholm
city: Stockholm
country: Sweden
facility: Research Site
state: Uppland
city: Sharjah
country: United Arab Emirates
facility: Research Site
state: Ash Shariqah
city: Dubai
country: United Arab Emirates
facility: Research Site
state: Dubayy
city: Dubai
country: United Arab Emirates
facility: Research Site
state: Dubayy
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
Study officials:
References: