Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 105
- Locations
- 13
- Primary Endpoint
- Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SLE Patients
Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.
Intervention: Anifrolumab (Drug)
Outcomes
Primary Outcomes
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
Time Frame: at month 12
Secondary Outcomes
- Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score(at month 6, 18, 24;)
- Change from index date in Physician Global Assessment (PGA) score(at month 6, 12, 18, 24;)
- Proportion of patients attaining the composite endpoint of modified SLE Responder Index (mSRI)(at month 6, 12, 18, 24;)
- Proportion of patients attaining the composite endpoint of Lupus Low Disease Activity State (LLDAS)(at month 6, 12, 18, 24)
- Proportion of patients achieving the composite endpoint of remission(at month 6, 12, 18,24)
- Proportion of patients receiving antimalarials, immunosuppressives, Non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids(every 6 months)
- Change from index date in corticosteroids dose(at month 6, 12, 18, 24)
- Proportion of steroid-free patients at every 6 months(every 6 months)
- Proportion of patients able to reach ≤5 mg/day of prednisolone equivalent dose at month 6, 12, 18, 24(at month 6, 12, 18, 24)
- Proportion of patients with 0-25%; 26-50%; 51-75%; 76-100% glucocorticoids (GCS) dose reduction(at month 6, 12, 18, 24)
- Anifrolumab treatment adherence(very 6 months)
