Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 358
- 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 dose and time span of Remicade between infusions for ankylosing spondylitis (AS).
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 ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.
排除标准
- •Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- •Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
- •Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
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 24 months
Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
时间窗: Maximum of 24 months
Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
时间窗: Maximum of 24 months.
Median Remicade Dose Per Participant
时间窗: Maximum of 24 months
Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
时间窗: Maximum of 24 months.
Mean Remicade Dose Per Participant
时间窗: Maximum of 24 months
次要结局
未报告次要终点