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

AstraZeneca

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Other: None (Observational study)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06046534

D3461R00058

Details and patient eligibility

About

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.

Full description

This is a multi-country, multi-site retrospective chart review study that will use data extracted from the medical charts of SLE patients who participated in the anifrolumab EAPs AMANA or ATUc in France, Germany, Greece, Israel, Italy, Portugal, Spain, and the UK. Patient level data will be captured longitudinally for each patient over a 12- to 18-month period. The study period will include retrospective data collection covering a minimum 6- month baseline period prior to the index date and retrospective data collection covering a minimum 6-month FU period from the first Anifrolumab infusion. The index date is defined as the date of first anifrolumab infusion during the indexing period. The indexing period is between the earliest date of patient enrolment into the EAP and the date of last new patient enrolment into EAP. The EAPs have closed by end of February 2023 in all countries included in the ERYTHRO study. One data extraction will be performed per patient.

Enrollment: 46 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 1 patient group

Cohort

Description:

SLE patients who participated in the anifrolumab EAPs (AMANA or ATUc).

Treatment:

Other: None (Observational study)