Clinical trial NCT06046534: Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Official title: ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: chronic autoimmune disease
immunosuppressants
corticosteroids
human monoclonal antibody (IgG1ƙ mAb)
Real World
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: CernerEnviza / Oracle
First posted: 2023-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6-month longitudinal data capture
measure: Disease activity assessed by the Physician Global Assessment (PGA) at 6 months from the date of first anifrolumab infusion
timeFrame: 6-month longitudinal data capture
Secondary outcomes:
measure: 1. Proportion of patients achieving SLE remission at 6 months from the date of first anifrolumab infusion
timeFrame: 6-month longitudinal data capture
measure: 2. Proportion of patients achieving all four criteria for low disease activity (LLDAS) at 6 months from first anifrolumab infusion
timeFrame: 6-month longitudinal data capture
measure: 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.
timeFrame: 6-month longitudinal data capture
measure: 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
timeFrame: 6-month longitudinal data capture
measure: 5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)
timeFrame: 12- to 18-month longitudinal data capture
measure: 6. Usage of anifrolumab, including adherence
timeFrame: 12- to 18-month longitudinal data capture
measure: 7. Usage of anifrolumab, including persistence
timeFrame: 12- to 18-month longitudinal data capture
measure: 8. Baseline patient characteristics
timeFrame: 12- to 18-month longitudinal data capture
measure: 9. Describe baseline comorbidities described by Charlson Comorbidity Index (CCI) or any of its components
timeFrame: 12- to 18-month longitudinal data capture
measure: 10. SLE related tests performed during baseline and FU, respectively
timeFrame: 12- to 18-month longitudinal data capture
measure: 11. SLE related tests performed during baseline and FU, respectively
timeFrame: 12- to 18-month longitudinal data capture
measure: 12. SLE related tests performed during baseline and FU, respectively
timeFrame: 12- to 18-month longitudinal data capture
measure: 13. SLE related tests performed during baseline and FU, respectively
timeFrame: 12- to 18-month longitudinal data capture
Other outcomes:
Locations:
city: Brest
country: France
facility: Research Site
city: Caen cedex 9
country: France
facility: Research Site
city: DIJON Cedex
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Ramat Gan
country: Israel
facility: Research Site
city: Tel Aviv-Yafo
country: Israel
facility: Research Site
city: Pisa -PI-
country: Italy
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Coslada, Madrid
country: Spain
facility: Research Site
city: Valladolid
country: Spain
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
Study officials:
References: