Real Life Treatment Regimen of Remicade (Infliximab) in Austria, Monitored Over 5 Years in Plaque Psoriasis Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
研究概览
简要总结
Prospective, open-label-, 1-arm, multicenter observational study to determine the dose and interval of Infliximab infusions for subjects with plaque psoriasis.
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
- 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
- •According to the European Summary of Product Characteristics (SPC): Adult subjects with moderate-to-severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapy including cyclosporine, methotrexate, or Psoralen-ultraviolet-A light (PUVA).
排除标准
- •According to the European SPC:
- •Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- •Subjects with moderate-to-severe heart failure (New York Heart Association (NYHA) class III/IV).
- •Subjects with a history of hypersensitivity to Infliximab or to other murine proteins or to any of the excipients.
- •Subjects with elevated liver enzymes (>5 upper limit of normal (ULN)).
结局指标
主要结局
Number of Therapies That Were Applied as Induction, Maintenance, or Episodic Therapies After One Infusion of Infliximab
时间窗: Maximum 2 years
The types of therapies were assessed according to the following criteria: Induction therapy: first infusion given at Week 0 (Baseline). Second infusion given at Week 2 (+/- 7 days). Third infusion given at Week 6 (+/- 7 days). Maintenance therapy: given in approximately 8-week (56-day) intervals (time window +4 weeks to -2 weeks). One infusion given out of the time window was accepted to be classified as maintenance therapy, if the remaining infusions were given within the time window (8 weeks, +4 to -2 weeks). Episodic Therapy: given out of time frame (\> 12 weeks).
次要结局
- Median Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy(Maximum 2 years)
- Median Dose of Infliximab(Maximum 2 years)
- Mean Percent Change From Baseline in Body Surface Area (BSA) Involved With Psoriasis After Treatment With Infliximab(Baseline and Infusion 9)
- Mean Time Interval Between Infliximab Infusions During Maintenance Treatment Following Induction Therapy(Maximum 2 years)
- Mean Dose of Infliximab(Maximum 2 years)