Systemic Lupus ErythematosusERYTHRONCT06046534
Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 15 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- None (Observational study)
- How many people
- 46 participants
- Where
- 15 sitesin 7 countries
- Study dates
- 27 Oct 2023to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 7 countries.
15 sites in 7 countries
France6 sites
Research Site
Brest
Research Site
Caen
Research Site
Dijon
Research Site
Lille
Research Site
Paris
Research Site
Toulouse
Spain3 sites
Research Site
Barcelona
Research Site
Coslada, Madrid
Research Site
Valladolid
About this study
Official title: ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- None (Observational study)
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), Real World
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Not applicable since this is observational study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | SLE patients who participated in the anifrolumab EAPs (AMANA or ATUc). Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- - mild
- - moderate
- - severe
Measured: 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
Remission: defined as clinical SLEDAI = 0, and PGA < 0.5. The patients may be on antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives, including biologics
Measured: 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
LLDAS assessment requires all of the following criteria to be met:
- SLEDAI-2K score ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, or fever),
- No new SLEDAI-2K assessed disease activity compared with the previous visit,
- PGA score ≤ 1,
- Prednisone or equivalent dosage ≤ 7.5 mg/day, and
- No non-standard immunosuppressant dosing, with antimalarials allowed.
Measured: 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.
Worsening of symptoms, referred to as flares, will be defined based on the the Revised Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index Flare Index (rSFI). Flares will be categorized into mild/moderate and severe flares as per the rSFI definitions.
Measured: 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
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) consists of 2 scores; the first summarizes the activity of the disease and the second is a measure of the damage done by the disease. Activity is scored on the basis of erythema, scale/hypertrophy of skin and mucous membranes, acute hair loss, and nonscarring alopecia. Damage is scored in terms of dyspigmentation and scarring, including scarring alopecia.
Study participants are asked whether dyspigmentation due to cutaneous lupus erythematosus lesions usually remains visible for more than 12 months, which is taken to be permanent. If the dyspigmentation lasts longer than 12 months after the active lesion has resolved, then the score is doubled. The scores are calculated by simple addition and range from 0-70 for activity and 0-56 for damage, with higher scores indicating worse disease activity/damage.
Measured: 6-month longitudinal data capture
5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)
- Pre- Anifrolumab treatment/ OCS usage before anifrolumab initiation
- Treatment concomitant with Anifrolumab / OCS usage concomitant with Anifrolumab
- Post-Anifrolumab treatment/ OCS usage after anifrolumab end/discontinuation.
Measured: 12- to 18-month longitudinal data capture
6. Usage of anifrolumab, including adherence
Adherence is the actual number of infusions received out of the expected number of infusions during a specified duration
Measured: 12- to 18-month longitudinal data capture
7. Usage of anifrolumab, including persistence
Persistence is the time on treatment as per indicated treatment interval
Measured: 12- to 18-month longitudinal data capture
8. Baseline patient characteristics
- Demographics (age, gender, ethnicity)
- Patients medical history
- Family history of autoimmune diseases
- Baseline comorbid conditions
- SLE treatment history
- Lifestyle (smoking history, alcohol consumption history)
Measured: 12- to 18-month longitudinal data capture
9. Describe baseline comorbidities described by Charlson Comorbidity Index (CCI) or any of its components
Charlson Comorbidity Index (CCI) predicts the mortality for a patient who may have a range of concurrent conditions, includes 17 chronic diseases in estimating the CCI. The CCI predicts 10- year mortality risk from chronic comorbidities.
Measured: 12- to 18-month longitudinal data capture
10. SLE related tests performed during baseline and FU, respectively
Whole blood tests
Measured: 12- to 18-month longitudinal data capture
11. SLE related tests performed during baseline and FU, respectively
Biochemical
Measured: 12- to 18-month longitudinal data capture
12. SLE related tests performed during baseline and FU, respectively
Serological
Measured: 12- to 18-month longitudinal data capture
13. SLE related tests performed during baseline and FU, respectively
Urine test
Measured: 12- to 18-month longitudinal data capture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Oct 2023
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CernerEnviza / Oracle
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046534
- Sponsor's protocol ID
- D3461R00058
- Acronym
- ERYTHRO
- Status last verified
- May 2025
- First submitted
- 27 Jun 2023
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERYTHRO Retrospective Medical Chart Review Study to Describe the Experience of SLE Patients Treated With Anifrolumab in the Early Access Programs.
- ClinicalTrials.gov ID
- NCT06046534
- Acronym / sponsor ID
- ERYTHRO / D3461R00058
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- chronic autoimmune disease, immunosuppressants, corticosteroids, human monoclonal antibody (IgG1ƙ mAb), Real World
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- CernerEnviza / Oracle
- Study start
- 27 Oct 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Other: None (Observational study)SLE patients who participated in the anifrolumab EAPs (AMANA or ATUc). |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Not applicable since this is observational study. | Other | Cohort |
Primary outcome
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
Time frame: 6-month longitudinal data capture
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.
Disease activity assessed by the Physician Global Assessment (PGA) at 6 months from the date of first anifrolumab infusion
Time frame: 6-month longitudinal data capture
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
13 secondary outcomes
1. Proportion of patients achieving SLE remission at 6 months from the date of first anifrolumab infusion
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 6-month longitudinal data capture
5. SLE treatments used before, during and after Anifrolumab, especially oral corticosteroids (OCS)
Time frame: 12- to 18-month longitudinal data capture
6. Usage of anifrolumab, including adherence
Time frame: 12- to 18-month longitudinal data capture
7. Usage of anifrolumab, including persistence
Time frame: 12- to 18-month longitudinal data capture
8. Baseline patient characteristics
Time frame: 12- to 18-month longitudinal data capture
9. Describe baseline comorbidities described by Charlson Comorbidity Index (CCI) or any of its components
Time frame: 12- to 18-month longitudinal data capture
10. SLE related tests performed during baseline and FU, respectively
Time frame: 12- to 18-month longitudinal data capture
11. SLE related tests performed during baseline and FU, respectively
Time frame: 12- to 18-month longitudinal data capture
12. SLE related tests performed during baseline and FU, respectively
Time frame: 12- to 18-month longitudinal data capture
13. SLE related tests performed during baseline and FU, respectively
Time frame: 12- to 18-month longitudinal data capture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 15 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Spain, Israel, Greece, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6-month longitudinal data capture). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.