Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2028-06-30

Brief Summary

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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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Detailed Description

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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

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Lupus Erythematosus, Systemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SLE Patients

Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.

Anifrolumab

Intervention Type DRUG

Anifrolumab 300 mg concentrate for solution for infusion

Interventions

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Anifrolumab

Anifrolumab 300 mg concentrate for solution for infusion

Intervention Type DRUG

Other Intervention Names

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Saphnelo

Eligibility Criteria

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Inclusion Criteria

1. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.
2. Patients willing to participate in the study and signed Informed Consent Form (ICF).

Exclusion Criteria

1. 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.
2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No