Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 105
- 试验地点
- 13
- 主要终点
- Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
SLE Patients
Open-lable arm with SLE patients who received anifrolumab treatment in the frames of NDP in Poland.
干预措施: Anifrolumab (Drug)
结局指标
主要结局
Change from index date in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
时间窗: at month 12
次要结局
- 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)