10-year Follow-up of Patients With Rheumatoid Arthritis Who Received Structured Treat-to-target Therapy in Early Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 11
- 主要终点
- Progression of radiographs joint damage
研究概览
简要总结
The ARCTIC-FORWARD study is a multi-center prospective observational study investigating the long-term outcomes of rheumatoid arthritis (RA) patients who received structured treat-to-target therapy early in their disease. The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs.
详细描述
Rheumatoid arthritis (RA) is one of the most common autoimmune diseases. Recent developments in RA treatment has shown to change the outcome of RA for the early stages of the disease, with very limited loss of work participation and high rates of disease activity remission. The data on the long-term outcome for patients who received early optimal treatment is much more limited, and it is of special clinical interest to know to what extent these patients should be monitored with regards to slowly evolving joint damage, subclinical inflammation, loss of physical function and loss of work participation.
The aim of this study is to assess clinical, radiographic and functional long-term outcomes of modern RA care and to identify risk factors for progressive disease.The main hypothesis of this project is that RA treat-to-target strategies during the first two years of disease result in beneficial long-term outcomes both with regards to joint damage, disease activity and societal costs. We will perform an extensive evaluation of all patients participating in the ARCTIC study 10 years after the initiation of structured treat-to-target therapy. Outcomes include disease activity, radiographic damage, functional status, DMARD use, extra-articular manifestations including interstitial lung disease, comorbidities, survival, work participation, health care resource use, and health related quality of life.
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
- •All patients that entered the ARCTIC study are eligible for the follow-up study. The main inclusion criteria in the ARCTIC study were age 18-75 years, fulfilment of the 2010 ACR classification criteria for RA, DMARD naivety with indication from DMARD therapy, and symptom duration of less than two years.
排除标准
- •Psychiatric or mental disorders, alcohol abuse, other substance abuse, other factors making adherence to the study protocol impossible
结局指标
主要结局
Progression of radiographs joint damage
时间窗: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Radiographs of hands and feet
Disease activity remission
时间窗: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Remission based on disease activity score (DAS)
Disease activity
时间窗: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by the disease activity score (DAS)
Physical and mental health
时间窗: At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study)
Assessed by SF-36
次要结局
- Tender joints(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Osteoporosis(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Physician global assessment of disease activity(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Health-related quality of life(10 At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Pulmonary function(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Grip strength(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Patient reported impact of disease(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Swollen joint count(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Tender joint count(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Erythrocyte sedimentation rate (ESR)(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Presence of rheumatoid noduli(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Medication use(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Ultrasound inflammation(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- C-reactive protein (CRP)(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Patient global assessment of disease activity(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Comorbidities(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Interstitial lung disease(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Physical activity level(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Patient reported Physical function(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
- Work Productivity(At the ARCTIC-FORWARD examination (10 years after initial inclusion into the ARCTIC study))
研究者
Siri Lillegraven
Senior researcher, Leader of Unit for clinical research
Diakonhjemmet Hospital