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

• ClinicalTrials.gov Identifier: NCT05637112
• Recruitment Status: Recruiting
• First Posted: December 5, 2022
• Last Update Posted: May 6, 2023
• Sponsor: AstraZeneca
• Collaborator: Parexel
• Information provided by (Responsible Party): AstraZeneca

Study Description

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.

Condition or disease	Intervention/treatment
Systemic Lupus Erythematosus	Other: None (Observational study)

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follow-up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study.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

Study Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: February 27, 2023
• Estimated Primary Completion Date: March 15, 2029
• Estimated Study Completion Date: March 15, 2029

Groups and Cohorts

Group/Cohort	Intervention/treatment
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: None (Observational study); Not Applicable since Observational Study; Other Name: Observational Study

Outcome Measures

Primary Outcome Measures :

1. Disease activity assessed by the Physician Global Assessment (PGA) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 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).
2. Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 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.
3. Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   The proportion of patients attaining the composite endpoint of LLDAS will be assesed.

Secondary Outcome Measures :

1. 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 3 years post-anifrolumab initiation ]
   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.
2. 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 3 years post-anifrolumab initiation ]
   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.
3. SLE treatment patterns prior to, concomitant with and after anifrolumab [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   SLE treatment patterns will be analyzed through prevalence and incidence in respect to time to discontinuation.
4. 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 ]
   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).
5. Lupus Quality of Life (LupusQoL) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   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.
6. Patient Global Assessment (PtGA) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   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).
7. 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 ]
   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.
8. Work Productivity and Activity Impairment - Lupus (WPAI:lupus) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   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.
9. Pain Numerical Rating Scale (NRS) [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
   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).
10. Number of outpatient hospital and emergency room visits and procedures [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
    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.
11. Number of hospital admissions and inpatient hospital procedures [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
    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.
12. Number of rheumatologist visits and procedures [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
    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.
13. Number of dialysis appointments [ Time Frame: From Baseline (1 year pre-anifrolumab) until follow-up 3 years post-anifrolumab initiation ]
    The HCRU for SLE after anifrolumab initiation as recorded in medical records will be assessed. The number of dialysis appointments will be assessed.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 130 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.
• 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.

Contacts and Locations

Contacts

Contact: AstraZeneca Clinical Study Information Center; 1-877-240-9479; information.center@astrazeneca.com

Locations

Austria

Research Site; Not yet recruiting

Graz, Styria, Austria, 8036

Research Site; Not yet recruiting

Innsbruck, Tirol, Austria, 6020

Research Site; Not yet recruiting

Linz, Upper Austria, Austria, 4020

Research Site; Withdrawn

Vienna, Austria, 1140

Canada, Alberta

Research Site; Not yet recruiting

Calgary, Alberta, Canada, T2N 4N1

Canada, Manitoba

Research Site; Not yet recruiting

Winnipeg, Manitoba, Canada, RR149

Canada, Ontario

Research Site; Not yet recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Research Site; Not yet recruiting

Toronto, Ontario, Canada, M5T 2S9

Canada, Quebec

Research Site; Not yet recruiting

Rimouski, Quebec, Canada, G5L 5T1

Research Site; Not yet recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

Research Site; Not yet recruiting

Ste-Foy, Quebec, Canada, G1V 4G2

Denmark

Research Site; Not yet recruiting

Copenhagen, Capital Region, Denmark, 2100

Research Site; Withdrawn

Aarhus N, Central Denmark Region, Denmark, 8200

Research Site; Not yet recruiting

Aalborg, North Denmark, Denmark, 9000

France

Research Site; Not yet recruiting

Nice CEDEX, Alpes-Maritimes, France, 06000

Research Site; Not yet recruiting

Strasbourg, Bas-Rhin, France, 67098

Research Site; Not yet recruiting

Bordeaux Cedex, Gironde, France, 33076

Research Site; Not yet recruiting

Grenoble, Isère, France, 38043

Research Site; Not yet recruiting

Nantes, Loire-Atlantique, France, 44093

Research Site; Not yet recruiting

Paris, France, 75013

Research Site; Not yet recruiting

Paris, France, 75014

Research Site; Not yet recruiting

Paris, France, 75020

Research Site; Not yet recruiting

Paris, France, 75475

Germany

Research Site; Not yet recruiting

Heidelberg, Baden Wuerttemberg, Germany, 69120

Research Site; Not yet recruiting

Erlangen, Bayern, Germany, 91054

Research Site; Not yet recruiting

Bad Bramstedt, Hamburg, Germany, 24576

Research Site; Not yet recruiting

Munich, Monachium, Germany, 81925

Research Site; Not yet recruiting

Planegg, Monachium, Germany, 82152

Research Site; Not yet recruiting

Düsseldorf, North Rhine-Westphalia, Germany, 40225

Research Site; Not yet recruiting

Herne, North Rhine-Westphalia, Germany, 44649

Research Site; Not yet recruiting

Köln, North Rhine-Westphalia, Germany, 30625

Research Site; Recruiting

Mainz A. Rhein, Rheinland-Pfalz, Germany, 55131

Research Site; Not yet recruiting

Magdeburg, Sachsen-Anhalt, Germany, 39104

Research Site; Not yet recruiting

Erfurt, Thuringia, Germany, 99096

Research Site; Not yet recruiting

Greifwald, Vorpommern-Greifswald, Germany, 17489

Research Site; Not yet recruiting

Berlin, Germany, 10117

Israel

Research Site; Not yet recruiting

Tiberias, Galilee, Israel, 15208

Research Site; Not yet recruiting

Haifa, Haifa District, Israel, 3109601

Research Site; Not yet recruiting

Haifa, Haifa District, Israel, 3436212

Research Site; Not yet recruiting

Kfar-Saba, HaMerkaz, Israel, 4428164

Research Site; Not yet recruiting

Ramat-Gan, Tel Aviv District, Israel, 52621

Research Site; Not yet recruiting

Tel Aviv, Tel Aviv District, Israel, 6423906

Italy

Research Site; Not yet recruiting

Firenze, Italy, 50134

Research Site; Not yet recruiting

Milano, Italy, 20132

Research Site; Not yet recruiting

Pisa, Italy, 56126

Research Site; Not yet recruiting

Roma, Italy, 00161

Sweden

Research Site; Recruiting

Orebro, Närke, Sweden, 70185

Research Site; Not yet recruiting

Stockholm, Uppland, Sweden, 171 76

Sponsors and Collaborators

AstraZeneca

Parexel

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05637112
• Other Study ID Numbers: D3461R00043
• First Posted: December 5, 2022
• Last Update Posted: May 6, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

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.

• 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.
• URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:

chronic autoimmune disease; immunosuppressants; corticosteroids; human monoclonal antibody (IgG1ƙ mAb); Real World

Additional relevant MeSH terms:

Lupus Erythematosus, Systemic; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases