Real Life Dosing Regimen of Remicade in Austria, Monitored Over 9 Consecutive Infusions in Rheumatoid Arthritis Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 516
- 主要终点
- Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
研究概览
简要总结
This is a prospective, open-label, 1-arm, multicenter observational study to determine the average Remicade dosage and time span between 9 infusions in subjects with rheumatoid arthritis (RA)
详细描述
This study population was chosen from a non-probability sample.
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
- •Severe RA (indication according to Austrian labeling).
排除标准
- •According to Summary of Product Characteristics (SPC).
结局指标
主要结局
Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
时间窗: Maximum of 16 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
时间窗: Maximum of 16 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
时间窗: Maximum of 102 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
时间窗: Maximum of 102 weeks
The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Median Remicade Dose Per Participant
时间窗: Maximum of 102 weeks
Mean Remicade Dose Per Participant
时间窗: Maximum of 102 weeks
次要结局
- Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy(24 months maximum)
- Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)(24 months maximum)
- Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS(24 months maximum)
- Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)(24 months maximum)