AZAHAR Study To Describe Anifrolumab in a Real-World Setting
NCT ID: NCT06626945
Last Updated: 2025-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
152 participants
OBSERVATIONAL
2025-02-03
2025-06-05
Brief Summary
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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.
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Detailed Description
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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:
1. 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.
2. 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.
3. To describe anifrolumab persistence and adherence rate over time during treatment with anifrolumab.
4. 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
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Josefina Cortés-Hernández, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón
Locations
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Research Site
Barcelona, , Spain
Research Site
Granada, , Spain
Research Site
Jaén, , Spain
Research Site
L'Hospitalet de Llobregat, , Spain
Research Site
León, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Mérida, , Spain
Research Site
Móstoles, , Spain
Research Site
Murcia, , Spain
Research Site
Seville, , Spain
Research Site
Toledo, , Spain
Research Site
Valladolid, , Spain
Countries
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References
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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.
Other Identifiers
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D3461R00080
Identifier Type: -
Identifier Source: org_study_id
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