The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 16
- 主要终点
- Remission
研究概览
简要总结
The LUNET Registry is intended to serve as a comprehensive primary data source, capturing real-world longitudinal clinical information, and the heterogeneity of patient presentations that are often underrepresented in traditional clinical trials. Ultimately, the LUNET Registry will help to optimize SLE management in routine clinical practice by enabling the compilation of real-world evidence to inform clinical decision-making and health policy. Patients will be enrolled by secondary and tertiary care centres for SLE across Italy in a real-world clinical set-up.
详细描述
The LUNET's specific objectives are as follows:
- Planning and conducting epidemiological studies to evaluate the incidence and prevalence rates of different clinical manifestations of SLE, and to evaluate short- and long-term outcomes, including survival rates and organ dysfunction, injury, and failure
- Promoting multicenter studies that will compare different patient subgroups based on clinical phenotypes and organ involvement, to attain insights regarding disease expression and progression
- Describing the profile of patients with lupus nephritis in the national population, to improve guidelines on its systematic and standardized assessment.
- Evaluating the presence of central and peripheral nervous system involvement in the national population of patients with SLE, assessing the type, frequency, and severity of neurological symptoms and objective signs, as well as the instrumental techniques used in clinical practice (e.g., Magnetic Resonance Imaging (MRI)
- Assessing biomarker data to support early diagnosis and guide treatment choices
- Improving screening techniques for early identification of organ damage in SLE patients
- Improving early treatment strategies
- Tracking adherence and response to therapy
- Evaluating the short- and long-term real-life effectiveness and safety of old and novel drugs approved for SLE, overall and in groups of patients with specific phenotypes
- Assessing SLE patients' quality of life according to clinical phenotype and treatment approach
- Assessing how socioeconomic status impacts patients' access to healthcare and absenteeism in relation to the disease and various therapeutic approaches
- Evaluating how different therapeutic strategies impact hospitalization
- Assessing the influence of old and novel therapies on fertility, pregnancy, and breastfeeding
- Monitoring cardiovascular risk in SLE patients by evaluating the associated comorbidities, prospective development of cardiovascular events, and biomarker levels (e.g., fasting blood glucose, hemoglobin A1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and pro-BNP)
- Evaluating bone metabolism in patients with SLE through assessment of laboratory measurements (e.g., vitamin D, calcium, phosphorus, calcinuria, and phosphaturia) and instrumental assessments, such as dual-energy X-ray absorptiometry (DEXA) scans
- Monitoring the causes of death among SLE patients
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
- •age ≥ 18 years;
- •confirmed SLE diagnosis according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria;
- •provision of signed written informed consent prior to participation
排除标准
- 未提供
结局指标
主要结局
Remission
时间窗: Every year to ten year
Number of patients who achieved complete clinical remission or low disease activity
Disease activity
时间窗: Every year to ten year
Changes in disease activity (SLEDAI-2k)
次要结局
未报告次要终点
