Clinical trial NCT06673043: Anifrolumab Real-world Treatment Outcomes in Systemic Lupus Erythematosus
Official title: Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lupus Erythematosus, Systemic
Keywords: Anifrolumab
systemic lupus erythematosus
SLE
observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult (aged ≥18 year old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland.

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
timeFrame: at month 12
Secondary outcomes:
measure: Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
timeFrame: at month 6, 18, 24;
measure: Change from index date in Physician Global Assessment (PGA) score
timeFrame: at month 6, 12, 18, 24;
measure: Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)
timeFrame: at month 6, 12, 18, 24;
measure: Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)
timeFrame: at month 6, 12, 18, 24
measure: Proportion of patients achieving the composite endpoint of remission
timeFrame: at month 6, 12, 18,24
measure: Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids
timeFrame: every 6 months
measure: Change from index date in corticosteroids dose
timeFrame: at month 6, 12, 18, 24
measure: Proportion of steroid-free patients at every 6 months
timeFrame: every 6 months
measure: Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24
timeFrame: at month 6, 12, 18, 24
measure: Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction
timeFrame: at month 6, 12, 18, 24
measure: Anifrolumab treatment adherence
timeFrame: very 6 months
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Research Site
city: Bytom
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krak W
country: Poland
facility: Research Site
city: L Dz
country: Poland
facility: Research Site
city: L Dz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Rzesz W
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
References: