Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus (SLE-ARTEMIS)

AstraZeneca

Status: Enrolling

Conditions: Lupus Erythematosus, Systemic

Treatments: Drug: Anifrolumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06673043

D3461R00082

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

SLE Patients

Description:

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

Treatment:

Drug: Anifrolumab