Non-interventional Study for Determining the Improvement in the Activity Status / Life Quality of Patients With Rheumatoid Arthritis Being Treated With the Tempus Tablet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,728
- 试验地点
- 1
- 主要终点
- Change in the QAS (Questionnaire on Activity Status)
研究概览
简要总结
Rheumatoid arthritis is the most common rheumatic disease with symptomatic morning stiffness which entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet.
详细描述
Rheumatoid arthritis is characterised with a sudden onset , with pains in the little finger or toe joints, progressively affecting various joints and symptomatic morning stiffness. For subjects with RA, morning stiffness entails a quite essential restriction in the everyday life and in the life quality. This observational, uncontrolled, multicentric study is aimed to assess the improvement in the activity status or QoL of subjects with RA being treated with the Tempus tablet. A total of 8,000 subjects with diagnosed, active RA will be included in the study The study will apply to 2 target groups: general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months; and specialists (rheumatologist) with an observation period of 9 months. Three subjects are expected per in-house doctor and 10 subjects per rheumatologist.
OBJECTIVES
Primary Objective:
- To examine, to what extent the subject will be directly benefited with the decrease in the morning arthritis symptom in the sense of an improvement in the life quality and the activity status
- The activity status will be assessed in 3 different areas: occupational activities, tasks in the household and leisure activities
- The life quality is assessed on the basis of the HAQ-DI
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
- •Subjects who correspond to the permitted indication of the drug of Lodotra
- •Subjects from age of 18 years with diagnosed, active RA with associated symptoms such as morning stiffness of the joints, which is either already being treated with low dose of glucocorticoids or will be treated again with glucocorticoid therapy
排除标准
- •- Subjects with contraindications are excluded from the participation
研究组 & 干预措施
NIS in-house doctors
This group will be assigned to general physicians, practicing doctors and interns (in-house doctors) with an observation period of 3 months. Three subjects are expected per in-house doctor therefore altogether, 1000 in-house doctors will be obtained or appointed for the observation study.
干预措施: Prednisone (Drug)
NIS specialists
This group will be assigned to specialists (rheumatologist) with an observation period of 9 months. Ten subjects per rheumatologist are expected therefore altogether, 500 rheumatologists will be obtained or appointed for the observation study.
干预措施: Prednisone (Drug)
结局指标
主要结局
Change in the QAS (Questionnaire on Activity Status)
时间窗: Beginning of the examination (gross-root survey) and after 3 months (follow-up)
次要结局
- Laboratory results (c reactive protein [CRP], BSG), X-rays (if available)(Beginning until after 9 months)
- QAS comparison after 9 months(Beginning until after 9 months)
- Performance by visual analog scale (VAS)(Beginning until after 9 months)
- Concurrent medication(Beginning until after 9 months)
- Health Assessment Questionnaire Disability Index (HAQ-DI) (NIS specialists)(Beginning until after 9 months)
- Side-effects and undesirable events(Beginning until after 9 months)