Remicade Therapy in Psoriatic Arthritis: 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
- 178
- 主要终点
- Mean Time Interval Between Infusions During Maintenance 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 interval of Remicade (Infliximab) infusions in psoriatic arthritis (PsA).
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
- •Participants with active and progressive psoriatic arthritis who have responded inadequately to disease-modifying anti-rheumatic drugs.
排除标准
- •All according to contraindications in the label especially:
- •Participants with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
- •Participants with moderate or severe heart failure (NYHA class III/IV).
- •Participants with a history of hypersensitivity to infliximab or to other murine proteins, or to any of the excipients.
结局指标
主要结局
Mean Time Interval Between Infusions During Maintenance Therapy
时间窗: Up to 24 months
The mean time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Median Time Interval Between Infusions During Maintenance Therapy
时间窗: Up to 24 months
The median time interval measured in days between Infliximab infusions in participants during the maintenance therapy (between infusion 3/4, 4/5, 5/6, 6/7, 7/8, 8/9) following induction therapy.
Average Dose During Induction Therapy and Subsequent Maintenance Therapy
时间窗: Up to 24 Months
The average dose per infusion measured in milligrams/killogram (mg/kg) in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Median Dose During Induction Therapy and Subsequent Maintenance Therapy
时间窗: Up to 24 Months
The median dose per infusion measured in mg/kg in participants receiving induction therapy and subsequent maintenance therapy (Infusions 1-3 were induction therapy and infusions 4-9 were maintenance therapy for a total of 9 consecutive infusions).
Average Overall Dose of All Infusions Per Participant
时间窗: Up to 24 Months
The average overall dose of all infusions among all Infliximab-naive participants measured in mg/kg.
Median Dose of All Infusions Per Participant
时间窗: Up to 24 Months
The median dose of all infusions among all Infliximab-naive participants measured in mg/kg.
次要结局
未报告次要终点