Systemic Lupus ErythematosusASTERNCT05637112
A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice.
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 74 sites in 9 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- None (Observational study)
- How many people
- 551 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 27 Feb 2023to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
France18 sites
Research Site
Bordeaux, Gironde, 33076
Research Site
Bouches-du-Rh Ne, Lyon, 69003
Research Site
Clermont-Ferrand, Auvergne-Rh ne-Alpes, 63000
Research Site
Dijon, C te-d'Or, 21079
Research Site
Finist Re, Brest Cedex, 29609
Research Site
FORT de France Cedex, Martinique, 97261
Research Site
Grenoble, Is Re, 38043
Research Site
Lille, Nord, 59037
Research Site
Nantes, Loire-Atlantique, 44093
Research Site
Nice, Alpes-Maritimes, 6000
Research Site
Paris, 14033
Research Site
Paris, 75013
Research Site
Paris, 75014
Research Site
Paris, 75020
Research Site
Paris, 75475
Research Site
Saint-Denis, La R Union, 97405
Research Site
Seine-Maritime, Rouen, 76230
Research Site
Strasbourg, Bas-Rhin, 67098
Italy16 sites
Research Site
Ancona, 60126
Research Site
Bari, 70124
Research Site
Brescia, Lombardy, 25100
Research Site
Cagliari, Sardinia, 9042
Research Site
Cona, Emilia-Romagna, 44124
Research Site
Florence, 50134
Research Site
Milan, Lombardy, 20122
Research Site
Milan, 20122
Research Site
Milan, 20132
Research Site
Naples, Campania, 80131
Research Site
Pisa, 56126
Research Site
Roma, 161
Research Site
Roma, 168
Research Site
Rome, Lazio, 149
Research Site
Turin, Piedmont, 10126
Research Site
Udine, Friuli Venezia Giulia, 33100
Germany13 sites
Research Site
Bad Bramstedt, Free and Hanseatic City of Hamburg, 24576
Research Site
Berlin, 10117
Research Site
Cologne, North Rhine-Westphalia, 51149
Research Site
D Sseldorf, North Rhine-Westphalia, 40225
Research Site
Erlangen, Bavaria, 91054
Research Site
Greifswald, Mecklenburg-Vorpommern, 17493
Research Site
Greifwald, Vorpommern-Greifswald, 17489
Research Site
Heidelberg, Baden-W Rttemberg, 69120
Research Site
Heidelberg, Baden-Wurttemberg, 69120
Research Site
Herne, North Rhine-Westphalia, 44649
Research Site
Magdeburg, Saxony-Anhalt, 39104
Research Site
Mainz A. Rhein, Rhineland-Palatinate, 55131
Research Site
Schleswig-Holstein, L Beck, 23562
Israel9 sites
Research Site
Afula, Northern District, 18101
Research Site
Haifa, Haifa District, 3109601
Research Site
Haifa, Haifa District, 3436212
Research Site
Jerusalem, Jerusalem, 91120
Research Site
Kfar Saba, Central District, 4428164
Research Site
Ramat Gan, Tel Aviv, 52621
Research Site
Tel Aviv, Tel Aviv, 6423906
Research Site
Tel Hashomer, Central District, 5211401
Research Site
Tiberias, Galilee, 15208
Canada8 sites
Research Site
Calgary, Alberta, T2N 4N1
Research Site
Hamilton, Ontario, L8N 3Z5
Research Site
Orillia, Ontario, L3V 1T5
Research Site
Rimouski, Quebec, G5L 5T1
Research Site
Sherbrooke, Quebec, J1G 2E8
Research Site
Ste-Foy, Quebec, G1V 4G2
Research Site
Toronto, Ontario, M5T 2S9
Research Site
Winnipeg, Manitoba, RR149
Austria3 sites
Research Site
Innsbruck, Tyrol, 6020
Research Site
Linz, Upper Austria, 4020
Research Site
Vienna, 1180
United Arab Emirates3 sites
Research Site
Abu Dhabi
Research Site
Dubai, Dubayy, 7272
Research Site
Sharjah city, Emirate of Sharjah, 72772
Sweden2 sites
Research Site
Örebro, N Rke, 70185
Research Site
Stockholm, Uppland, 171 76
About this study
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
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.
Read the 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 up to 5 years of follow-up data.
The minimum enrolment period is anticipated to be 18 months (± 5 months) per country, but it may 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). Data collection will continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study. Relevant clinical data collection will continue for the entire follow up while patient reported outcome (PRO) data collection will continue only up to the 3-year follow up.
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- None (Observational study)
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), Real World
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational Study
Not Applicable since Observational Study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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)
The proportion of patients attaining the Definition of Remission in SLE will be assesed.
Measured: 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)
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.
Measured: 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).
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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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 utilisation (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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 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.
Measured: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start27 Feb 2023
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 551 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637112
- Sponsor's protocol ID
- D3461R00043
- Acronym
- ASTER
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39578022
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05637112
- Acronym / sponsor ID
- ASTER / D3461R00043
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), Real World
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 551 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 up to 5 years of follow-up data.
The minimum enrolment period is anticipated to be 18 months (± 5 months) per country, but it may 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). Data collection will continue for all patients including those who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study. Relevant clinical data collection will continue for the entire follow up while patient reported outcome (PRO) data collection will continue only up to the 3-year follow up.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: None (Observational study)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. |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Also: Observational StudyNot Applicable since Observational Study | Other | Prospective Cohort |
Primary outcome
Disease activity assessed by the Physician Global Assessment (PGA)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
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).
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
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.
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The proportion of patients attaining the composite endpoint of LLDAS will be assesed.
14 secondary outcomes
Proportion of patients attaining Definition of Remission in SLE (DORIS)
Time frame: 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)
Time frame: 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).
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
SLE treatment patterns prior to, concomitant with and after anifrolumab
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Lupus Quality of Life (LupusQoL)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Patient Global Assessment (PtGA)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
EuroQol 5-Dimension Health Questionnaire 5 Level (EQ-5D-5L)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Work Productivity and Activity Impairment - Lupus (WPAI:lupus)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Pain Numerical Rating Scale (NRS)
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation
Number of outpatient hospital and emergency room visits and procedures
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Number of hospital admissions and inpatient hospital procedures
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Number of rheumatologist visits and procedures
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Number of dialysis appointments
Time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Derived from this study: PubMed 39578022Mosca 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.
- Individual participant dataSharing planned: Yes. 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.
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Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 74 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in France, Italy, Germany, Israel, Canada and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity assessed by the Physician Global Assessment (PGA) (time frame: From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.