Real Life Dosing Regimen of Remicade in Austria in Crohn's Disease - Program Extension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 348
- 主要终点
- Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
研究概览
简要总结
The current observational program was determined to collect data on the real life dosing regimen of Remicade in patients with Crohn's disease (CD) in the hospital and non-hospital setting.
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
- •Subjects with active luminal and/or fistulizing CD.
排除标准
- •Per summary of product characteristics.
结局指标
主要结局
Mean Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
时间窗: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Median Interval Between Infliximab Infusions Within the Observation Period (Maintenance Therapy)
时间窗: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Average Dose of Infliximab Per Participant Within the Observation Period
时间窗: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Median Dose of Infliximab Per Participant Within the Observation Period
时间窗: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
Total Dose of Infliximab Per Participant Within the Observation Period
时间窗: up to 2 years
Participants received infliximab infusions with or without induction therapy. The induction therapy consisted of three infliximab infusions at Weeks 0, 2 and 6. Maintenance therapy consisted of an additional 6 infusions (maximum) as prescribed by the treating physician (dose and infusion interval).
次要结局
- Assessment of the Disease Activity Before Treatment and During Therapy With Remicade Via Harvey Bradshaw Index (HBI) in an Extended Patient Group of 200 Patients.(5 years)