Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

Last updated: July 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Systemic Lupus Erythematosus

Lupus

Cutaneous Lupus Erythematosus

Treatment

Anifrolumab

Clinical Study ID

NCT06673043
D3461R00082
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment inthe frames of NDP in Poland.

  2. Patients willing to participate in the study and signed Informed Consent Form (ICF).

Exclusion

Exclusion Criteria:

  1. Those who participated in anifrolumab clinical trial in the past, and/or those whoparticipated/plans to participate in clinical trial on/after the date of firstanifrolumab infusion through NDP.

  2. Cognitive incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Anifrolumab
Phase:
Study Start date:
February 28, 2025
Estimated Completion Date:
June 30, 2028

Study 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).

Connect with a study center

  • Research Site

    Bydgoszcz,
    Poland

    Active - Recruiting

  • Research Site

    Bytom,
    Poland

    Active - Recruiting

  • Research Site

    Gdansk,
    Poland

    Active - Recruiting

  • Research Site

    Katowice,
    Poland

    Site Not Available

  • Research Site

    Krak W,
    Poland

    Site Not Available

  • Research Site

    Krakow,
    Poland

    Active - Recruiting

  • Research Site

    L Dz,
    Poland

    Site Not Available

  • Research Site

    Lodz,
    Poland

    Active - Recruiting

  • Research Site

    Lublin,
    Poland

    Active - Recruiting

  • Research Site

    Poznan,
    Poland

    Site Not Available

  • Research Site

    Rzesz W,
    Poland

    Site Not Available

  • Research Site

    Rzeszow,
    Poland

    Active - Recruiting

  • Research Site

    Szczecin,
    Poland

    Site Not Available

  • Research Site

    Warszawa,
    Poland

    Site Not Available

  • Research Site

    Wroc?aw,
    Poland

    Active - Recruiting

  • Research Site

    Wroclaw,
    Poland

    Site Not Available

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