Prospective Registry of Patients With Systemic Lupus Erythematosus of the Argentinian Society of Rheumatology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- mortality
研究概览
简要总结
In Latin America, information about patients with systemic lupus erythematosus (SLE) is limited. Multicenter studies are needed to obtain "real world data '' and to carry out longer follow-ups. The purpose of this project is to design a cohort of Argentinian patients with SLE to describe "our real setting" and to identify possible limitations in access to specialized consultations and treatments.
详细描述
A longitudinal and multicenter cohort study of patients with systemic lupus erythematosus (SLE) is planned, with a follow-up of for 5 years. The data will be obtained from the clinical history of each patient. The responsible for data collection will always be a physician with experience in the management of patients with SLE and who has received training for data loading.
The data will be collected through the an electronic case report form (eCRF) specially designed for this record and which in turn will facilitate the control of the data and the generation of inquiries to the researchers.
STUDY VARIABLES
Baseline visit:
Sociodemographic data Classification criteria American College of Rheumatology (ACR 1982/1997), Systemic Lupus International Collaborating Clinics (SLICC 2012) and/or European League Against Rheumatism / American College of Rheumatology (EULAR / ACR 2019) History of SLE Access to specialized care Current clinical manifestations Activity and damage Scores Current treatments Patient-Reported Outcomes (PROs): Self-reported quality of life questionnaires EQ-5R; physician global assessment (PGA) and the patient Comorbidities Vaccination Habits Obstetric history Associated antiphospholipid syndrome Hospitalizations for adverse event, infections, or lupus activity
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients ≥ 18 years of age
- •Classified as SLE (according to the 1982/1997 American College of Rheumatology criteria and/or Systemic Lupus International Collaborating Clinics criteria for SLE)
- •Less than 5 years from meeting SLE criteria
- •Informed consent signature
排除标准
- •Diagnosis of other systemic autoimmune diseases or overlap syndromes
- •Patients who have been transferred to other centers
结局指标
主要结局
mortality
时间窗: 1 year
Annual and global mortality during the follow up period
disease activity
时间窗: 1 year
Changes in disease activity (SLEDAI)
patient reported outcomes
时间窗: 1 year
Impact on the quality of life and working life measured by PROs
remission
时间窗: 1 year
Number of patients who achieved complete clinical remission or LDAS
accrual damage
时间窗: 1 year
change in accrual damage (SLICC)
次要结局
- treatment(1 year)
- drug survival(1 year)
- adverse events(1 year)