Prospective Study of Evolution of Rheumatoid Arthritis After 65 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Number of cancers
研究概览
简要总结
Rheumatoid arthritis (RA) is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. Few data are available regarding the prevalence and severity of these comorbidities in elderly RA patients. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA.
详细描述
Prevalence of rheumatoid arthritis (RA) in elderly is increasing because of the increasing life expectancy. RA is associated with a higher prevalence of infections, malignancies, osteoporotic fractures and cardiovascular diseases. The purpose of this study is to determine the effect of age on prevalence and severity of comorbidities in RA. This study also aims to determine whether age influences disease progression and efficacy and tolerance of treatments.
This study will compare two groups of patients : patients older than 65 years old and patients younger than 50 years old, matched for gender and disease duration.
The first part of the study will be cross-sectional and will aim to compare characteristics regarding RA manifestations and comorbidities of the two groups at inclusion.
Whereas the second part will be prospective to assess the occurrence of comorbidities and the efficacy and safety of treatments in these two groups. Patients will be assessed every year during 5 years in accordance with usual follow-up of the patients.
This study could help to better manage elderly RA patients and to modify clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Clinical diagnosis of Rheumatoid arthritis according to American College of Rheumatology (ACR) /Eular 2010 criteria or American College of Rheumatalogy 1987 criteria
- •Age >65 years or patients between 18 and 50 years matched for sex and disease duration with the group of elderly patients (control group)
排除标准
- •Patients who do not understand rules and implications of the study
结局指标
主要结局
Number of cancers
时间窗: 5 years
Occurrence of solid cancer or hemopathy
Number of cardiovascular diseases
时间窗: 5 years
Occurrence of myocardial infarction or stroke
Number of severe infections
时间窗: 5 years
Occurrence of severe infection requiring hospitalization or varicella-zoster virus
Number of osteoporotic fractures
时间窗: 5 years
次要结局
- Number of synovitis and/or tenosynovitis at ultrasound of hands(5 years)
- Simple Disease Activity Index (SDAI)(5 years)
- Measure of C-reactive protein (CRP)(5 years)
- Disease Activity Score (DAS 28)(5 years)
- Erythrocyte sedimentation rate(5 years)
- Health assessment questionnaire (HAQ) score(5 years)
- Need of orthopaedic surgery(5 years)
- Number of erosions at X-rays (hands and feet)(5 years)
- Number of cataracts(5 years)
- Number of diabetes, arterial hypertension and dyslipidaemia(5 years)
- Number of vaccinations(5 years)