Remicade Treatment Registry in Rheumatoid Arthritis I
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment
研究概览
简要总结
This study will gather information on the safety and efficacy of patients with rheumatoid arthritis (RA) who are starting treatment with infliximab for the first time. Patients will be treated in the usual manner according to local guidelines and normal clinical practice.
详细描述
Local patients, diagnosed with RA at the National Institute of Rheumatic Diseases, Piestany, Slovakia, can participate, if their physicians have decided to treat the patient with infliximab. Registration for the trial will be done on a voluntary basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have been given patient leaflet,
- •Subject must not have ever received infliximab at the time of registration,
- •Subject must be a good candidate for infliximab as per Summary of Product Characteristics
- •Subject must sign the approved consent form
排除标准
- 未提供
研究组 & 干预措施
Rheumatoid Arthritis Patients in Slovakia
Rheumatoid arthritis patients in Slovakia who are starting treatment with infliximab for the first time, in accordance with normal clinical practice.
干预措施: Infliximab (Drug)
结局指标
主要结局
Average Change in Disease Activity Score 28 (DAS 28) From the Beginning of the Treatment
时间窗: Baseline, Week 14, and Week 54
The DAS 28 is an assessment of disease activity based on swollen joint count, erythrocyte sedimentation rate, and general health. Participants can be scored on a range of 0 to 10, with lower scores indicating less disease activity.
Number of Participants Fulfilling Criteria for a Therapeutic Response According to the European League Against Rheumatism (EULAR) Response Criteria
时间窗: Week 14 and Week 54
Response to treatment was assessed by EULAR response criteria. According to these criteria, participants were characterized as good, moderate, or non-responders based on both DAS level attained and change in DAS. Good response was defined as \>1.2 improvement in DAS from Baseline and DAS attained during follow-up of ≤2.4. Non-responders were participants with improvement of ≤0.6 or participants with improvement of \>0.6 but ≤1.2 and DAS attained during follow-up of \>3.7. Remaining participants were classified as moderate. Scores of good and moderate were considered to have therapeutic response.
次要结局
未报告次要终点