Observational study of anifrolumab in patients with systemic lupus erythematosus
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
Run by AstraZeneca · NCT06626945 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study looks at how well anifrolumab works for adults with systemic lupus erythematosus by tracking their health and treatment experiences during the first year of using the medication.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 130 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab |
| Locations | 13 sites (Barcelona and 12 other locations) |
| Trial ID | NCT06626945 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 years or older who meet the 2019 EULAR/ACR criteria for SLE and have initiated treatment with anifrolumab within the specified timeframe.
✕Probably not a fit
Patients who have previously been exposed to anifrolumab through clinical trials or Early Access Programs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The AZAHAR study is an observational, retrospective, and longitudinal analysis focusing on adults with systemic lupus erythematosus (SLE) who began treatment with anifrolumab between June 1, 2023, and May 31, 2024, in Spain. The study aims to gather real-world evidence regarding the characteristics and clinical outcomes of these patients during the first year of anifrolumab's commercialization. Key objectives include assessing disease activity, flare incidence rates, and treatment adherence over an 18-month period. Data will be collected at the initiation of treatment and every six months thereafter.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of anifrolumab for patients with SLE in a real-world setting.
How similar studies have gone: While this study is observational and focuses on real-world evidence, similar studies have shown promising results with anifrolumab in controlled clinical settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).
Where it's running
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Research Site
Barcelona, Spain Recruiting -
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Granada, Spain Recruiting -
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Jaen, Spain Recruiting -
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L'Hospitalet de Llobregat, Spain Recruiting -
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Leon, Spain Recruiting -
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Madrid, Spain Recruiting
Show 7 more locations
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Research Site
Malaga, Spain Recruiting -
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Merida, Spain Recruiting -
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Mostoles, Spain Recruiting -
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Murcia, Spain Recruiting -
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Sevilla, Spain Recruiting -
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Toledo, Spain Recruiting -
Research Site
Valladolid, Spain Recruiting
Study contacts
- Principal investigator: Josefina Cortés-Hernández, MD, PhD — Unit of Lupus, VHIR-Hospital Universitary Vall d'Hebrón
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
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Effects of anifrolumab on arterial inflammation in SLE patients
This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.
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Long-Term Extension of enpatoran for cutaneous lupus symptoms
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Targeting B cells and plasma cells in lupus with a dual-action antibody
A new injectable therapy (F182112) will be tested in adults with systemic lupus erythematosus to see if it can help by hitting both CD3 on immune cells and BCMA on B cells and plasma cells.
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FT839 therapy for autoimmune diseases
This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.
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Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.