Observational study of anifrolumab in patients with systemic lupus erythematosus
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
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab |
| Locations | 13 sites (Barcelona and 12 other locations) |
| Trial ID | NCT06626945 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have previously been exposed to anifrolumab through clinical trials or Early Access Programs may not benefit from this study.
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 performed: While this study is observational and focuses on real-world evidence, similar studies have shown promising results with anifrolumab in controlled clinical settings.
Eligibility criteria
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 this trial is running
Barcelona and 12 other locations
- Research Site — Barcelona, Spain (Recruiting)
- Research Site — Granada, Spain (Recruiting)
- Research Site — Jaen, Spain (Recruiting)
- Research Site — L'Hospitalet de Llobregat, Spain (Recruiting)
- Research Site — Leon, Spain (Recruiting)
- Research Site — Madrid, Spain (Recruiting)
- Research Site — Malaga, Spain (Recruiting)
- Research Site — Merida, Spain (Recruiting)
- Research Site — Mostoles, Spain (Recruiting)
- Research Site — Murcia, Spain (Recruiting)
- Research Site — Sevilla, Spain (Recruiting)
- Research Site — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.