Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score
研究概览
简要总结
The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome "SS") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome "pSS" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.
详细描述
Primary Sjögren's syndrome (pSS) affects 0,1% of the population. This systemic autoimmune disease is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of patients. No treatment has proven effective in this disease. The previous or present systemic complications included skin, articular, lung, kidney, peripheral and central nervous system, muscular involvement and vasculitis, as well as lymphoma occurrence were recorded. For previous lymphoma, the diagnosis and the histological subtypes were confirmed by reanalysis of the medical and histological records. The objective of this cohort was to assess systemic complications (signs) and evolution of patients with pSS and to determine the evolution and factors predictors of lymphoma of systemic complications and lymphoma in pSS during a 20-years prospective follow-up. This cohort was successful in rheumatology field, 395 patients was recruited for 2 years in 15 French centers (10 rheumatology and internal medicine 5) and followed for 5 years until July 2014.
The primary objective of this cohort is to assess the evolution of Primitive Sjogren Syndrome patients and to determine predictors factors of lymphoma and systemic complications during a 20-years prospective follow-up.
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
- •aged of 18 years or more
- •Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS
排除标准
- •secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases
结局指标
主要结局
Number of patients with systemic complications during the follow-up assessed with European League Against Rheumatism (EULAR) Sjögren Syndrome Disease Activity index (ESSDAI) activity score and ESSPRI score
时间窗: From the beginning of the study until the end of the 20 years follow-up
To assess the evolution of patients with primary Sjogren's Syndrome, determine the incidence of systemic complications
number of patient developing a lymphoma
时间窗: From the beginning of the study until the end of the 20 years follow-up
To determine the incidence of lymphomas in patients with primary Sjogren's Syndrome
Variation of complications during the follow-up assessed with ESSDAI activity score and EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) score
时间窗: From the beginning of the study until the end of the 20 years follow-up
次要结局
- Biological report (Blood test)(From the beginning of the study until the end of the 20 years follow-up)
- number of patients with cancer(From the beginning of the study until the end of the 20 years follow-up)
- number of patients with cardiovascular complication(From the beginning of the study until the end of the 20 years follow-up)
- List of drugs taken by the patients(From the beginning of the study until the end of the 20 years follow-up)