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

NCT ID: NCT06046534

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-27

Study Completion Date

2024-06-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort

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

None (Observational study)

Intervention Type OTHER

Not applicable since this is observational study.

Interventions

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None (Observational study)

Not applicable since this is observational study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CernerEnviza / Oracle

UNKNOWN

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Brest, , France

Site Status

Research Site

Caen, , France

Site Status

Research Site

Dijon, , France

Site Status

Research Site

Lille, , France

Site Status

Research Site

Paris, , France

Site Status

Research Site

Toulouse, , France

Site Status

Research Site

Athens, , Greece

Site Status

Research Site

Ramat Gan, , Israel

Site Status

Research Site

Tel Aviv, , Israel

Site Status

Research Site

Pisa -PI-, , Italy

Site Status

Research Site

Porto, , Portugal

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Coslada, Madrid, , Spain

Site Status

Research Site

Valladolid, , Spain

Site Status

Research Site

Leeds, , United Kingdom

Site Status

Countries

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France Greece Israel Italy Portugal Spain United Kingdom

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3461R00058&attachmentIdentifier=6d51a344-2089-4475-a738-7c8eb3b1edc9&fileName=ERYTHRO_AZ_CSR_Synopsis.pdf&versionIdentifier=

CSR Synopsis

Other Identifiers

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D3461R00058

Identifier Type: -

Identifier Source: org_study_id

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