CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- SLE epidemiology and presentation,
研究概览
简要总结
Prospective, observational registry for subjects with SLE under the care of a rheumatology provider. Longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.
详细描述
The objective of the registry is to create a cohort of Systemic lupus erythematosus (SLE) subjects to evaluate long-term real-world safety and effectiveness of standard of care treatments for SLE. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of SLE, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs. Further, data collected will inform clinical decision making by patients and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization data.
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
- •To be eligible to participate in this registry, an individual must meet all the following criteria:
- •Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
- •Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
- •Willing and able to provide informed consent.
- •Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, and home address zip/postal code at a minimum) if required based on registry location and applicable laws and regulations.
- •In addition, subjects must meet at least one of the following criteria:
- •New diagnosis of SLE (=<12 months) from registry enrollment, OR
- •Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR
- •Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in the registry:
- •Is participating in a double-blind clinical trial for a SLE drug
- •Subjects participating in any non-blinded trial for any indication, with the exception of non-blinded CAR-T or other cell/gene therapies for the treatment of SLE
研究组 & 干预措施
未命名试验
干预措施: Blood Collection (Other)
结局指标
主要结局
SLE epidemiology and presentation,
时间窗: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the presentation and natural history.
SLE management, and outcomes
时间窗: Every 6 months for 10 years
The major clinical outcome include an assessment of the epidemiology of Systemic Lupus Erythematosus; to better understand the management and outcomes.
次要结局
未报告次要终点