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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05637112




Registration number
NCT05637112
Ethics application status
Date submitted
24/11/2022
Date registered
5/12/2022

Titles & IDs
Public title
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Scientific 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
Secondary ID [1] 0 0
D3461R00043
Universal Trial Number (UTN)
Trial acronym
ASTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - None (Observational study)

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 interventions: None (Observational study)
Not Applicable since Observational Study
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease activity assessed by the Physician Global Assessment (PGA)
Timepoint [1] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Primary outcome [2] 0 0
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Timepoint [2] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Primary outcome [3] 0 0
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
Timepoint [3] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [1] 0 0
Proportion of patients attaining Definition of Remission in SLE (DORIS)
Timepoint [1] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [2] 0 0
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)
Timepoint [2] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [3] 0 0
Proportion of patients with irreversible organ damage, using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI).
Timepoint [3] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [4] 0 0
SLE treatment patterns prior to, concomitant with and after anifrolumab
Timepoint [4] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [5] 0 0
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
Timepoint [5] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [6] 0 0
Lupus Quality of Life (LupusQoL)
Timepoint [6] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [7] 0 0
Patient Global Assessment (PtGA)
Timepoint [7] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [8] 0 0
EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)
Timepoint [8] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [9] 0 0
Work Productivity and Activity Impairment - Lupus (WPAI:lupus)
Timepoint [9] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [10] 0 0
Pain Numerical Rating Scale (NRS)
Timepoint [10] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [11] 0 0
Number of outpatient hospital and emergency room visits and procedures
Timepoint [11] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [12] 0 0
Number of hospital admissions and inpatient hospital procedures
Timepoint [12] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [13] 0 0
Number of rheumatologist visits and procedures
Timepoint [13] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Secondary outcome [14] 0 0
Number of dialysis appointments
Timepoint [14] 0 0
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2029
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Styria
Country [2] 0 0
Austria
State/province [2] 0 0
Tirol
Country [3] 0 0
Austria
State/province [3] 0 0
Upper Austria
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Belgium
State/province [5] 0 0
Oost Vlaanderen
Country [6] 0 0
Belgium
State/province [6] 0 0
West Flanders
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Liege
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
Manitoba
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Denmark
State/province [13] 0 0
Capital Region
Country [14] 0 0
Denmark
State/province [14] 0 0
Central Denmark Region
Country [15] 0 0
Denmark
State/province [15] 0 0
North Denmark
Country [16] 0 0
France
State/province [16] 0 0
Alpes Maritimes
Country [17] 0 0
France
State/province [17] 0 0
Auvergne Rhone Alpes
Country [18] 0 0
France
State/province [18] 0 0
Bas Rhin
Country [19] 0 0
France
State/province [19] 0 0
Brest Cedex
Country [20] 0 0
France
State/province [20] 0 0
Cote dOr
Country [21] 0 0
France
State/province [21] 0 0
Gironde
Country [22] 0 0
France
State/province [22] 0 0
Isere
Country [23] 0 0
France
State/province [23] 0 0
La Reunion
Country [24] 0 0
France
State/province [24] 0 0
Loire Atlantique
Country [25] 0 0
France
State/province [25] 0 0
Lyon
Country [26] 0 0
France
State/province [26] 0 0
Martinique
Country [27] 0 0
France
State/province [27] 0 0
Nord
Country [28] 0 0
France
State/province [28] 0 0
Rouen
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Germany
State/province [30] 0 0
Baden Wuerttemberg
Country [31] 0 0
Germany
State/province [31] 0 0
Baden Wurttemberg
Country [32] 0 0
Germany
State/province [32] 0 0
Bayern
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Lubeck
Country [35] 0 0
Germany
State/province [35] 0 0
Mecklenburg Vorpommern
Country [36] 0 0
Germany
State/province [36] 0 0
Monachium
Country [37] 0 0
Germany
State/province [37] 0 0
Nordrhein Westfalen
Country [38] 0 0
Germany
State/province [38] 0 0
North Rhine Westphalia
Country [39] 0 0
Germany
State/province [39] 0 0
Rheinland Pfalz
Country [40] 0 0
Germany
State/province [40] 0 0
Sachsen Anhalt
Country [41] 0 0
Germany
State/province [41] 0 0
Thuringia
Country [42] 0 0
Germany
State/province [42] 0 0
Vorpommern Greifswald
Country [43] 0 0
Germany
State/province [43] 0 0
Berlin
Country [44] 0 0
Israel
State/province [44] 0 0
Galilee
Country [45] 0 0
Israel
State/province [45] 0 0
HaDarom
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa District
Country [47] 0 0
Israel
State/province [47] 0 0
HaMerkaz
Country [48] 0 0
Israel
State/province [48] 0 0
Northern District
Country [49] 0 0
Israel
State/province [49] 0 0
Tel Aviv District
Country [50] 0 0
Israel
State/province [50] 0 0
Yerushalayim
Country [51] 0 0
Italy
State/province [51] 0 0
Campania
Country [52] 0 0
Italy
State/province [52] 0 0
Emilia Romagna
Country [53] 0 0
Italy
State/province [53] 0 0
Friuli Venezia Giulia
Country [54] 0 0
Italy
State/province [54] 0 0
Lazio
Country [55] 0 0
Italy
State/province [55] 0 0
Lombardia
Country [56] 0 0
Italy
State/province [56] 0 0
Piemonte
Country [57] 0 0
Italy
State/province [57] 0 0
Sardegna
Country [58] 0 0
Italy
State/province [58] 0 0
Ancona
Country [59] 0 0
Italy
State/province [59] 0 0
Bari
Country [60] 0 0
Italy
State/province [60] 0 0
Firenze
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
Country [62] 0 0
Italy
State/province [62] 0 0
Pisa
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
Country [64] 0 0
Sweden
State/province [64] 0 0
Narke
Country [65] 0 0
Sweden
State/province [65] 0 0
Stockholm
Country [66] 0 0
Sweden
State/province [66] 0 0
Uppland
Country [67] 0 0
United Arab Emirates
State/province [67] 0 0
Ash Shariqah
Country [68] 0 0
United Arab Emirates
State/province [68] 0 0
Dubayy
Country [69] 0 0
United Arab Emirates
State/province [69] 0 0
Abu Dhabi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05637112