Lupus Erythematosus, SystemicSLE-ARTEMISNCT06673043
Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 11 sites in Poland.
Trial summary
The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- Anifrolumab
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 11 sitesPoland
- Study dates
- 28 Feb 2025to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
Who may be able to join
- Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
- Patients willing to participate in the study and signed Informed Consent Form (ICF).
Who cannot join
- Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Poland11 sites
Research Site
Bydgoszcz
Research Site
Bytom
Research Site
Gdansk
Research Site
Katowice
Research Site
Krakow
Research Site
Lodz
Research Site
Lublin
Research Site
Poznan
Research Site
Rzeszów
Research Site
Warsaw
Research Site
Wroclaw
About this study
Official title: Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
The Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.
Read the detailed description
This is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with SLE that received anifrolumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 30 months (~ 6 months baseline and ~24 months follow-up date).
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- Anifrolumab
- Keywords
- Anifrolumab, systemic lupus erythematosus, SLE, observational
- 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.
AnifrolumabDrug
Also called Saphnelo
Anifrolumab 300 mg concentrate for solution for infusion
| Study group | Role | What they receive |
|---|---|---|
| SLE Patients | Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland. Receives: Drug: Anifrolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Measured: at month 12
Secondary outcomes (11)
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Measured: at month 6, 18, 24;
Change from index date in Physician Global Assessment (PGA) score
Measured: at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)
mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points
Measured: at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)
LLDAS defined as: SLEDAI-2K ≤4, with no activity in major organ systems and no haemolytic anaemia or gastrointestinal activity; no new lupus disease activity compared with previous assessment; PGA ≤1; current prednisone(-equivalent) dose ≤7.5mg/day; well-tolerated standard maintenance dose of immunosuppressive drugs and biologics if any.
Measured: at month 6, 12, 18, 24
Proportion of patients achieving the composite endpoint of remission
Disease activity index (cSLEDAI)=0, PGA <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.
Measured: at month 6, 12, 18,24
Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids
Measured: every 6 months
Change from index date in corticosteroids dose
Measured: at month 6, 12, 18, 24
Proportion of steroid-free patients at every 6 months
Measured: every 6 months
Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24
Measured: at month 6, 12, 18, 24
Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction
Measured: at month 6, 12, 18, 24
Anifrolumab treatment adherence
Comparison of actual and expected number of infusions (%) evaluate
Measured: very 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start28 Feb 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies 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
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673043
- Sponsor's protocol ID
- D3461R00082
- Acronym
- SLE-ARTEMIS
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 Vivli.org. All requests 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
- ClinicalTrials.gov ID
- NCT06673043
- Acronym / sponsor ID
- SLE-ARTEMIS / D3461R00082
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Anifrolumab, systemic lupus erythematosus, SLE, observational
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 4 Nov 2024 (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 Polish multicentre observational (non-interventional) study aiming to collect data on the characteristic of patients with systemic lupus erythematosus and clinical outcomes of anifrolumab administered in the scope of routine clinical practice.
Detailed description
This is multicenter, observational, cohort study designed to collect longitudinal data on the management and clinical outcomes of patients with SLE that received anifrolumab in the scope of routine clinical practice within the frames of National Drug Program (NDP) for up to 30 months (~ 6 months baseline and ~24 months follow-up date).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE Patients | – | Drug: AnifrolumabOpen-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
Key inclusion criteria (2 listed)
- Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
- Patients willing to participate in the study and signed Informed Consent Form (ICF).
Key exclusion criteria (2 listed)
- Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP.
- Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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 |
|---|---|---|
| AnifrolumabAlso: SaphneloAnifrolumab 300 mg concentrate for solution for infusion | Drug | SLE Patients |
Primary outcome
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Time frame: at month 12
11 secondary outcomes
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Time frame: at month 6, 18, 24;
Change from index date in Physician Global Assessment (PGA) score
Time frame: at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)
Time frame: at month 6, 12, 18, 24;
Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)
Time frame: at month 6, 12, 18, 24
Proportion of patients achieving the composite endpoint of remission
Time frame: at month 6, 12, 18,24
Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids
Time frame: every 6 months
Change from index date in corticosteroids dose
Time frame: at month 6, 12, 18, 24
Proportion of steroid-free patients at every 6 months
Time frame: every 6 months
Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24
Time frame: at month 6, 12, 18, 24
Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction
Time frame: at month 6, 12, 18, 24
Anifrolumab treatment adherence
Time frame: very 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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 Vivli.org. All requests 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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic, run by AstraZeneca at 11 sites in Poland.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score (time frame: at month 12). 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 18 Sep 2026.