NCT06046534Completed
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Source: ClinicalTrials.gov · Last updated 13 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 46 (actual)
- First submitted
- 27 Jun 2023
- Start date
- 27 Oct 2023
- Primary completion date
- 10 Jun 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT06046534
What you commit to
- Study type: Observational
- Participants enrolled: 46
- From 27 Oct 2023 to the primary completion date, 10 Jun 2024
- 15 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participated in anifrolumab clinical trials, NCT02794285 (D3461C00009) and / or NCT01753193 (D3461C00003), prior to enrolment into AMANA or France ATUc program, or
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.