Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT06046534
Status:
COMPLETED
Last Update Posted:
2025-05-13
First Post:
2023-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERYTHRO
Brief Summary:
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.
Detailed 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: