Status:
COMPLETED
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
CernerEnviza / Oracle
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-130 years
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 exp...
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 Fran...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 10 2024
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06046534
Start Date
October 27 2023
End Date
June 10 2024
Last Update
May 13 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Brest, France
2
Research Site
Caen, France
3
Research Site
Dijon, France
4
Research Site
Lille, France