Systemic Lupus Erythematosus (SLE)AZAHARNCT06626945
AZAHAR Study To Describe Anifrolumab in a Real-World Setting
An observational study of Systemic Lupus Erythematosus (SLE), run by AstraZeneca at 13 sites in Spain.
Trial summary
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024. The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 152 participants
- Where
- 13 sitesSpain
- Study dates
- 3 Feb 2025to 5 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population will include patients diagnosed with SLE who attended the specialist's office at the participating hospitals in the study and initiated anifrolumab during the following period, between June 1st, 2023, and May 31st, 2024.
Who may be able to join
- Fulfilled the 2019 EULAR/ACR criteria for SLE at the date of anifrolumab initiation.
- Aged 18 years or older at the date of anifrolumab initiation.
- Have initiated anifrolumab between June 1st, 2023, and May 31st, 2024
- Have at least 12 months of medical history prior to anifrolumab initiation.
Who cannot join
- Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Research Site
Barcelona
Research Site
Granada
Research Site
Jaén
Research Site
L'Hospitalet de Llobregat
Research Site
León
Research Site
Madrid
Research Site
Málaga
Research Site
Mérida
Research Site
Móstoles
Research Site
Murcia
Research Site
Seville
Research Site
Toledo
Research Site
Valladolid
About this study
Official title: AZAHAR Study. Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo (Anifrolumab) in a Real-World Setting
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.
The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain.
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by altered immune response with excessive cytokines and antibodies production. Immune response activation and maintained inflammatory status promote a multisystemic dysfunction affecting numerous organs.
Anifrolumab, a monoclonal antibody that binds to type 1 IFN, which it is involved in pathways altered in SLE , blocks its effects. In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE, compared to standard of care. This biologic treatment was marketed in Spain on June 1, 2023. This study aims to describe real world evidence of anifrolumab in Spain since its commercialization.
The primary objective is to describe disease activity (including low disease activity state, (LLDAS)) and clinical remission at the initiation with anifrolumab and every 6 months, up to 18 months, after anifrolumab initiation.
The secondary objectives are:
- To estimate the flare incidence rate, overall, and considering severe flares only, during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation.
- To describe SLE treatment, especially the use of corticosteroids (CS), during the previous 12 months before anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
- To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab.
- To describe healthcare resources utilization (HRU) for SLE during the previous 12 months before anifrolumab initiation and every 6 months, up to 18 months after anifrolumab initiation.
The exploratory objective is:
To describe organ damage at the anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
This is an observational retrospective and longitudinal chart review study including adults patients with moderate-severe SLE who initiated treatment with anifrolumab. Baseline data 12 months prior to anifrolumab treatment will be collected, and since anifrolumab initiation, participants will be followed-up until the closest available data to the end of the study (December 31st, 2024).
This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.
The expected sample size is around 120 patients from 20 hospitals in Spain.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Measured: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Physician Global Assessment (PGA) score
PGA ranges from 0 to 3, with 0 representing the total inactivity of the disease and 3 an important activity.
An increase of ≥1 score since the last visit is indicative of a flare.
Measured: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Changes in SLEDAI-2K score
Change from baseline in SLEDAI-2K score for consecutive timepoints.
Measured: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Changes in PGA score
Change from baseline in PGA score for consecutive timepoints.
Measured: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Proportion of patients achieving low disease activity state
LLDAS requires all the following criteria to be met:
- SLEDAI-2K score ≤ 4, with no activity in the major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever).
- No new SLEDAI-2K assessed disease activity compared to the previous visit.
- PGA score ≤ 1
- Prednisone or equivalent dosage ≤ 7.5 mg/day
- No non-standard immunosuppressant dosing, with antimalarials allowed.
Measured: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Proportion of patients achieving clinical remission
Clinical remission will be measured as DORIS-21, a composite endpoint including:
- Clinical SLEDAI score of 0 (no disease activity)
- PGA <0.5
- Prednisolone dose of 5 mg/day or less.
- Stable use of antimalarials, immunosuppressives, and biologics.
Measured: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Secondary outcomes (13)
Flares incidence rate
Flares is defined as worsening of symptoms based as assessed with a modified revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) flare index (rSFI) based on SLEDAI-2K assessment.
Measured: 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
Anifrolumab adherence
Proportion of anifrolumab infusions that happen every 18 to 38 days during a certain specified period from first anifrolumab infusion.
Measured: Up to 18 months since anifrolumab initiation.
Anifrolumab persistence
Time on treatment until discontinuation or end of follow-up
Measured: Up to 18 months since anifrolumab initiation.
Proportion of patients receiving any of dose of corticosteroids (CS)
CS include the following route of administration: oral, subcutaneous, intramuscular or intravenous.
Measured: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Annual cumulative dose of CS
Corticosteroids include the following route of administration: oral, subcutaneous, intramuscular or intravenous.
Measured: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months
Proportion of patients treated with any biologic treatment
Biologic treatment refers to any biologic medication (on-label and off-label) prescribed for SLE.
Measured: Previous 12 months before anifrolumab initiation.
Proportion of patients treated with any antimalarial medication
Antimalarial medication prescribed for SLE.
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Proportion of patients treated with any immunosuppressive medication
Immunosuppressive medication prescribed for SLE.
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Hospitalization rate attributable to SLE
Annual hospitalization rate expressed by patient-year
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Intensive care unit (ICU) admission rate attributable to SLE
Annual ICU admission rate expressed by patient-year
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Emergency room (ER) admission rate attributable to SLE
Annual ED admission rate expressed by patient-year
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Primary care (PC) visits rate attributable to SLE
Annual PC visits rate expressed by patient-year
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Specialist visits rate attributable to SLE
Annual specialist visits rate expressed by patient-year
Measured: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start3 Feb 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
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 Erythematosus (SLE)Studies 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
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josefina Cortés-Hernández, MD, PhD, Principal investigator, Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626945
- Sponsor's protocol ID
- D3461R00080
- Acronym
- AZAHAR
- Status last verified
- Jun 2026
- First submitted
- 26 Sep 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
Publications
Galindo-Izquierdo M, Bahamontes-Rosa N, Sarto-Ferres B, Galvez-Fernandez M, Cortes-Hernandez J. Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol. Lupus Sci Med. 2025 Feb 12;12(1):e001486. doi: 10.1136/lupus-2024-001486.
PubMed 39939126
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AZAHAR Study. Observational Retrospective Study To Describe Characteristics And Clinical Outcomes of Patients With Systemic Lupus Erythematosus Initiating Saphnelo (Anifrolumab) in a Real-World Setting
- ClinicalTrials.gov ID
- NCT06626945
- Acronym / sponsor ID
- AZAHAR / D3461R00080
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 4 Oct 2024 (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.
AZAHAR is an observational retrospective and longitudinal study with adults patients with SLE who initiated treatment with anifrolumab from June 1, 2023 to May 31, 2024.
The overall objective is to describe the characteristics and clinical outcomes of patients with SLE that initiated anifrolumab during its first year of commercialization in Spain.
Detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by altered immune response with excessive cytokines and antibodies production. Immune response activation and maintained inflammatory status promote a multisystemic dysfunction affecting numerous organs.
Anifrolumab, a monoclonal antibody that binds to type 1 IFN, which it is involved in pathways altered in SLE , blocks its effects. In clinical trials showed beneficial effects controlling the disease activity in patients with moderate and severe SLE, compared to standard of care. This biologic treatment was marketed in Spain on June 1, 2023. This study aims to describe real world evidence of anifrolumab in Spain since its commercialization.
The primary objective is to describe disease activity (including low disease activity state, (LLDAS)) and clinical remission at the initiation with anifrolumab and every 6 months, up to 18 months, after anifrolumab initiation.
The secondary objectives are:
- To estimate the flare incidence rate, overall, and considering severe flares only, during the previous 12 months before anifrolumab initiation and every 6 months up to 18 months after anifrolumab initiation.
- To describe SLE treatment, especially the use of corticosteroids (CS), during the previous 12 months before anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
- To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab.
- To describe healthcare resources utilization (HRU) for SLE during the previous 12 months before anifrolumab initiation and every 6 months, up to 18 months after anifrolumab initiation.
The exploratory objective is:
To describe organ damage at the anifrolumab initiation, and every 6 months, up to 18 months after anifrolumab initiation.
This is an observational retrospective and longitudinal chart review study including adults patients with moderate-severe SLE who initiated treatment with anifrolumab. Baseline data 12 months prior to anifrolumab treatment will be collected, and since anifrolumab initiation, participants will be followed-up until the closest available data to the end of the study (December 31st, 2024).
This study is based exclusively on secondary data collection from outpatient electronic medical records (EMRs). Therefore, it will rely on already existing data from patients by the time of data collection.
The expected sample size is around 120 patients from 20 hospitals in Spain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients diagnosed with SLE who attended the specialist's office at the participating hospitals in the study and initiated anifrolumab during the following period, between June 1st, 2023, and May 31st, 2024.
Key inclusion criteria (4 listed)
- Fulfilled the 2019 EULAR/ACR criteria for SLE at the date of anifrolumab initiation.
- Aged 18 years or older at the date of anifrolumab initiation.
- Have initiated anifrolumab between June 1st, 2023, and May 31st, 2024
- Have at least 12 months of medical history prior to anifrolumab initiation.
Key exclusion criteria (1 listed)
- Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Physician Global Assessment (PGA) score
Time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
PGA ranges from 0 to 3, with 0 representing the total inactivity of the disease and 3 an important activity. An increase of ≥1 score since the last visit is indicative of a flare.
Changes in SLEDAI-2K score
Time frame: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Change from baseline in SLEDAI-2K score for consecutive timepoints.
Changes in PGA score
Time frame: From anifrolumab initiation to 6, 12 and 18 months after anifrolumab initiation.
Change from baseline in PGA score for consecutive timepoints.
Proportion of patients achieving low disease activity state
Time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
LLDAS requires all the following criteria to be met: * SLEDAI-2K score ≤ 4, with no activity in the major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever). * No new SLEDAI-2K assessed disease activity compared to the previous visit. * PGA score ≤ 1 * Prednisone or equivalent dosage ≤ 7.5 mg/day * No non-standard immunosuppressant dosing, with antimalarials allowed.
Proportion of patients achieving clinical remission
Time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Clinical remission will be measured as DORIS-21, a composite endpoint including: * Clinical SLEDAI score of 0 (no disease activity) * PGA <0.5 * Prednisolone dose of 5 mg/day or less. * Stable use of antimalarials, immunosuppressives, and biologics.
13 secondary outcomes
Flares incidence rate
Time frame: 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months.
Anifrolumab adherence
Time frame: Up to 18 months since anifrolumab initiation.
Anifrolumab persistence
Time frame: Up to 18 months since anifrolumab initiation.
Proportion of patients receiving any of dose of corticosteroids (CS)
Time frame: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.
Annual cumulative dose of CS
Time frame: Previous 12 months before anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months
Proportion of patients treated with any biologic treatment
Time frame: Previous 12 months before anifrolumab initiation.
Proportion of patients treated with any antimalarial medication
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Proportion of patients treated with any immunosuppressive medication
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Hospitalization rate attributable to SLE
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Intensive care unit (ICU) admission rate attributable to SLE
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Emergency room (ER) admission rate attributable to SLE
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Primary care (PC) visits rate attributable to SLE
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Specialist visits rate attributable to SLE
Time frame: Previous 12 months before anifrolumab initiation and every 6 months after anifrolumab initiation, up to 18 months after anifrolumab initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 39939126Galindo-Izquierdo M, Bahamontes-Rosa N, Sarto-Ferres B, Galvez-Fernandez M, Cortes-Hernandez J. Characteristics and clinical outcomes of patients with systemic lupus erythematosus initiating anifrolumab in a real-world setting in Spain (AZAHAR study): an observational study protocol. Lupus Sci Med. 2025 Feb 12;12(1):e001486. doi: 10.1136/lupus-2024-001486.
- D3461R00080\_CSR SynopsisLink provided by the sponsor.
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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.
Josefina Cortés-Hernández, MD, PhD principal investigator
Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by AstraZeneca at 13 sites in Spain.
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 1 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: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (time frame: At anifrolumab initiation, and every 6 months after anifrolumab initiation, up to 18 months.). The study lists 6 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 NCT06626945, 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 4 Jun 2026.