NCT03389711Unknown不适用
INCMNSZ Early Rheumatoid Arthritis Cohort
National Institute of Medical Sciences and Nutrition, Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 237 人开始时间: 2004年2月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Disease activity status
研究概览
简要总结
Identify Rheumatoid Arthritis patients diagnose within first 12 months since the beginning of the disease related symptoms. Initiate proper treatment according to international standards in order to achieve remission/low disease activity status.
详细描述
- Provide an standardized follow up by a multidisciplinary specialized team.
- Create a biological (blood) bank to develop future research projects.
- Create a database with the clinical, serologic, radiographic and functional status patients data.
- Define comorbidities and mortality causes.
- Begin an educational program to improve patient disease self-knowledge
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
- •Patients ≥18 years old
- •Fulfilled ACR 1987 classification criteria for RA
- •Disease evolution of <1 year when first evaluated, and no specific rheumatic diagnosis except for RA.
排除标准
- •Patients with another rheumatic disease, except Sjögren syndrome.
研究组 & 干预措施
未命名试验
干预措施: DMARD´s and multidisciplinary treatment (Combination Product)
结局指标
主要结局
Disease activity status
时间窗: During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.
Describe the disease activity score using DAS 28 ESR
次要结局
- Change from Baseline of the Patient Reported Outcome : HAQ (Health Assessment Questionnarie)(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Change from Baseline of the Patient Reported Outcome : SF-36 (Short Form Health Survey)(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Change from Baseline of the Patient Reported Outcome: RADAI (Rheumatoid Arthritis Disease Activity Index)(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Predictors of health care drop-out(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Michigan Hand Outcome Questionnarie (MHQ(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH)(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
- Mayor Depressive Episodes (MDE)(During the first two years of follow up: the evaluations will be every 2 months. After those years: the evaluations will be every 2, 4 or 6 months depending on disease activity status.)
研究者
Virginia Pascual Ramos
Lead Investigator of the Rheumatoid Arthritis Clinic
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
研究点 (1)
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