Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
ERYTHRO
ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
1 other identifier
observational
46
7 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2023
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedStudy Start
First participant enrolled
October 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2024
CompletedMay 13, 2025
May 1, 2025
8 months
June 27, 2023
May 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) or any of its components at 6 months from the date of first anifrolumab infusion
The SLEDAI-2K stands for Systemic Lupus Erythematosus Disease Activity Index -2000. It measures disease activity in the 28 days prior to and at the time point of the assessment. It is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies (anti-dsDNA positive or negative) and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity. In practice it is expected that SLEDAI scores will be skewed towards 0, with scores higher than 20 being rare.
6-month longitudinal data capture
Disease activity assessed by the Physician Global Assessment (PGA) at 6 months from the date of first anifrolumab infusion
The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities). 0 - none 1. \- mild 2. \- moderate 3. \- severe
6-month longitudinal data capture
Secondary Outcomes (13)
1. Proportion of patients achieving SLE remission at 6 months from the date of first anifrolumab infusion
6-month longitudinal data capture
2. Proportion of patients achieving all four criteria for low disease activity (LLDAS) at 6 months from first anifrolumab infusion
6-month longitudinal data capture
3. The frequency overall and by intensity (mild / moderate and severe) of flares as assessed by the Revised Safety of Estrogens in Lupus National Assessment - SLE Disease Activity Index Flare Index (rSFI) at baseline and during follow up.
6-month longitudinal data capture
4. The extent of skin manifestations over time as described by Cutaneous LE Disease Area and Severity Index (CLASI) during baseline and at 6 months after the data of first anifrolumab infusion
6-month longitudinal data capture
5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)
12- to 18-month longitudinal data capture
- +8 more secondary outcomes
Study Arms (1)
Cohort
SLE patients who participated in the anifrolumab EAPs (AMANA or ATUc).
Interventions
Eligibility Criteria
The study population is defined as adult SLE patients enrolled in AMANA EAP or the anifrolumab France ATUc and meeting the inclusion and exclusion criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- CernerEnviza / Oraclecollaborator
Study Sites (15)
Research Site
Brest, France
Research Site
Caen, France
Research Site
Dijon, France
Research Site
Lille, France
Research Site
Paris, France
Research Site
Toulouse, France
Research Site
Athens, Greece
Research Site
Ramat Gan, Israel
Research Site
Tel Aviv, Israel
Research Site
Pisa -PI-, Italy
Research Site
Porto, Portugal
Research Site
Barcelona, Spain
Research Site
Coslada, Madrid, Spain
Research Site
Valladolid, Spain
Research Site
Leeds, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
September 21, 2023
Study Start
October 27, 2023
Primary Completion
June 10, 2024
Study Completion
June 10, 2024
Last Updated
May 13, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.