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
1 other identifier
observational
551
9 countries
79
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2030
February 24, 2026
February 1, 2026
7.8 years
November 24, 2022
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 5 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 5 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 5 years post-anifrolumab initiation
Secondary Outcomes (14)
Proportion of patients attaining Definition of Remission in SLE (DORIS)
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)
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).
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
SLE treatment patterns prior to, concomitant with and after anifrolumab
From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
- +9 more secondary outcomes
Study Arms (1)
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.
Interventions
Not Applicable since Observational Study
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (79)
Research Site
Innsbruck, Tyrol, 6020, Austria
Research Site
Linz, Upper Austria, 4020, Austria
Research Site
Vienna, 1180, Austria
Research Site
Liège, Li Ge, 4000, Belgium
Research Site
Aalst, Oost-Vlaanderen, 9300, Belgium
Research Site
Bruges, West Flanders, 8000, Belgium
Research Site
Leuven, 3000, Belgium
Research Site
Calgary, Alberta, T2N 4N1, Canada
Research Site
Winnipeg, Manitoba, RR149, Canada
Research Site
Hamilton, Ontario, L8N 3Z5, Canada
Research Site
Orillia, Ontario, L3V 1T5, Canada
Research Site
Toronto, Ontario, M5T 2S9, Canada
Research Site
Rimouski, Quebec, G5L 5T1, Canada
Research Site
Sherbrooke, Quebec, J1G 2E8, Canada
Research Site
Ste-Foy, Quebec, G1V 4G2, Canada
Research Site
Nice, Alpes-Maritimes, 6000, France
Research Site
Clermont-Ferrand, Auvergne-Rh ne-Alpes, 63000, France
Research Site
Strasbourg, Bas-Rhin, 67098, France
Research Site
Finist Re, Brest Cedex, 29609, France
Research Site
Dijon, C te-d'Or, 21079, France
Research Site
Bordeaux, Gironde, 33076, France
Research Site
Grenoble, Is Re, 38043, France
Research Site
Saint-Denis, La R Union, 97405, France
Research Site
Nantes, Loire-Atlantique, 44093, France
Research Site
Bouches-du-Rh Ne, Lyon, 69003, France
Research Site
FORT de France Cedex, Martinique, 97261, France
Research Site
Lille, Nord, 59037, France
Research Site
Seine-Maritime, Rouen, 76230, France
Research Site
Paris, 14033, France
Research Site
Paris, 75013, France
Research Site
Paris, 75014, France
Research Site
Paris, 75020, France
Research Site
Paris, 75475, France
Research Site
Heidelberg, Baden-W Rttemberg, 69120, Germany
Research Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
Research Site
Erlangen, Bavaria, 91054, Germany
Research Site
Bad Bramstedt, Hamburg, 24576, Germany
Research Site
Schleswig-Holstein, L Beck, 23562, Germany
Research Site
Greifswald, Mecklenburg-Vorpommern, 17493, Germany
Research Site
Munich, Monachium, 81925, Germany
Research Site
Cologne, North Rhine-Westphalia, 51149, Germany
Research Site
D Sseldorf, North Rhine-Westphalia, 40225, Germany
Research Site
Herne, North Rhine-Westphalia, 44649, Germany
Research Site
Mainz A. Rhein, Rhineland-Palatinate, 55131, Germany
Research Site
Magdeburg, Saxony-Anhalt, 39104, Germany
Research Site
Greifwald, Vorpommern-Greifswald, 17489, Germany
Research Site
Berlin, 10117, Germany
Research Site
Kfar Saba, Central District, 4428164, Israel
Research Site
Tel Hashomer, Central District, 5211401, Israel
Research Site
Tiberias, Galilee, 15208, Israel
Research Site
Haifa, Haifa District, 3109601, Israel
Research Site
Haifa, Haifa District, 3436212, Israel
Research Site
Jerusalem, Jerusalem, 91120, Israel
Research Site
Afula, Northern District, 18101, Israel
Research Site
Ramat Gan, Tel Aviv, 52621, Israel
Research Site
Tel Aviv, Tel Aviv, 6423906, Israel
Research Site
Naples, Campania, 80131, Italy
Research Site
Cona, Emilia-Romagna, 44124, Italy
Research Site
Udine, Friuli Venezia Giulia, 33100, Italy
Research Site
Rome, Lazio, 149, Italy
Research Site
Brescia, Lombardy, 25100, Italy
Research Site
Milan, Lombardy, 20122, Italy
Research Site
Turin, Piedmont, 10126, Italy
Research Site
Cagliari, Sardinia, 9042, Italy
Research Site
Ancona, 60126, Italy
Research Site
Bari, 70124, Italy
Research Site
Florence, 50134, Italy
Research Site
Milan, 20122, Italy
Research Site
Milan, 20132, Italy
Research Site
Pisa, 56126, Italy
Research Site
Roma, 161, Italy
Research Site
Roma, 168, Italy
Research Site
Örebro, N Rke, 70185, Sweden
Research Site
Danderyd, Stockholm County, 18288, Sweden
Research Site
Stockholm, Uppland, 171 76, Sweden
Research Site
Dubai, Dubayy, 7272, United Arab Emirates
Research Site
Dubai, Dubayy, United Arab Emirates
Research Site
Sharjah city, Emirate of Sharjah, 72772, United Arab Emirates
Research Site
Abu Dhabi, United Arab Emirates
Related Publications (1)
Mosca M, Emmas C, Nekeman-Nan C, Stirnadel-Farrant H, Chen S, Carty L, Waratani M, Seo C, Chen S, Sorrentino A. Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study. BMJ Open. 2024 Nov 21;14(11):e086055. doi: 10.1136/bmjopen-2024-086055.
PMID: 39578022DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2022
First Posted
December 5, 2022
Study Start
February 27, 2023
Primary Completion (Estimated)
December 30, 2030
Study Completion (Estimated)
December 30, 2030
Last Updated
February 24, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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.