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Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.

NCT06046534

CompletedN/A

Sponsor: AstraZeneca

Conditions: Systemic Lupus Erythematosus

Interventions: None (Observational study)

Countries: France, Greece, Israel, Italy, Portugal, Spain, United Kingdom

The ERYTHRO study is a retrospective medical chart review study of patients in the AMANA and ATUc Early Access Programs (EAPs) across a number of countries, to assess anifrolumab usage and patient experience in treating SLE in a real-world setting. Since patient safety data are already collected and reported according to regulatory requirements through EAPs, this study will not collect safety data.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years at time of enrolment into AMANA or France ATUc program, and
* Have at least 6 months of data from medical charts available prior to the initiation of anifrolumab through the EAP, and
* Have been initiated on anifrolumab at least 6 months before enrolment into ERYTHRO study, and
* Informed consent obtained (where required as per country regulations) to participate in ERYTHRO

Exclusion Criteria:

* Participated in anifrolumab clinical trials, NCT02794285 (D3461C00009) and / or NCT01753193 (D3461C00003), prior to enrolment into AMANA or France ATUc program, or
* Participated in any SLE clinical trial during the baseline period and / or the FU period of ERYTHRO, or
* Patients who were pregnant during the baseline period and / or the FU period of ERYTHRO

Locations (15)

Brest, France
Caen, France
Dijon, France
Lille, France
Paris, France
Toulouse, France
Athens, Greece
Ramat Gan, Israel
Tel Aviv, Israel
Pisa -PI-, Italy
Porto, Portugal
Barcelona, Spain
Coslada, Madrid, Spain
Valladolid, Spain
Leeds, United Kingdom