Kineret in the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Health Assessment Questionnaire
研究概览
简要总结
Objective of the study is to gain knowledge about the administration of Kineret in patients with rheumatoid arthritis in the daily routine treatment and not in controlled trials. In the current survey, the investigation of the response rate of Kineret regarding the date of onset of action, the efficacy, as well as the tolerability and safety are of particular interest.
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
- •Informed consent by the patient
- •Rheumatoid arthritis
- •Previous methotrexate therapy with inadequate response
排除标准
- •Pregnancy
结局指标
主要结局
Health Assessment Questionnaire
时间窗: 0-52 weeks
The patients will at each visit complete a questionnaire about their health status and the impairment in usual activities due to the rheumatoid disorder.
Disease Activity Score 28 (DAS28)
时间窗: 0-52 weeks
The DAS28 measures the progress and improvement of Rheumatoid Arthritis. DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission. Both the number of joints with tenderness upon touching and swelling are counted. In addition, the erythrocyte sedimentation rate is measured. Also, the patient makes a subjective assessment of disease activity during the preceding 7 days on a scale between 0 and 100, where 0 is "no activity" and 100 is "highest activity possible".
ACR response
时间窗: 0-52 weeks
The ACR (American College of Rheumatology) Criteria measures the effectiveness of treatments for Rheumatoid Arthritis. The ACR is reported as % improvement, comparing disease activity at two discrete time points.
次要结局
未报告次要终点