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NCT Number: NCT06673043

Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Bydgoszcz, Poland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Anifrolumab

Drug

Anifrolumab 300 mg concentrate for solution for infusion

Other names: Saphnelo

Primary outcomes

  1. Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

    Time frame: at month 12

Secondary outcomes

  1. Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

    Time frame: at month 6, 18, 24;

  2. Change from index date in Physician Global Assessment (PGA) score

    Time frame: at month 6, 12, 18, 24;

  3. Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)

    Time frame: at month 6, 12, 18, 24;

    mSRI defined as: a reduction in SLEDAI-2K ≥4 points with no worsening in PGA ≥0.3 points

  4. Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)

    Time frame: at month 6, 12, 18, 24

    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.

  5. Proportion of patients achieving the composite endpoint of remission

    Time frame: at month 6, 12, 18,24

    Disease activity index (cSLEDAI)=0, PGA <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.

  6. Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids

    Time frame: every 6 months

  7. Change from index date in corticosteroids dose

    Time frame: at month 6, 12, 18, 24

  8. Proportion of steroid-free patients at every 6 months

    Time frame: every 6 months

  9. 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

  10. Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction

    Time frame: at month 6, 12, 18, 24

  11. Anifrolumab treatment adherence

    Time frame: very 6 months

    Comparison of actual and expected number of infusions (%) evaluate

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study

Acronym: SLE-ARTEMIS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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