Assessment of Treatment Safety and Quality of Life in Patients Receiving Etanercept Biosimilar for Autoimmune Arthritis (ASQA): a Multicenter Post-marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 583
- 试验地点
- 9
- 主要终点
- Safety: incidence of adverse events
研究概览
简要总结
In this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. Safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months.
详细描述
In this open-label, multi-center, observational, post-marketing surveillance study, patients with ankylosing spondylitis, psoriatic arthritis, or rheumatoid arthritis received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly in real-world settings. Safety and effectiveness of biosimilar etanercept were evaluated in study participants for a duration of up to 12 months. Patient information was recorded in four notebooks, and each notebook had three sections, one section for each month. The first section of notebook I contained demographic information, pregnancy and lactation status in female patients, cigarette smoking and alcohol consumption, and past medical history. All safety and effectiveness outcomes were recorded at the appropriate sections of the notebooks.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adults with the diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis receiving biosimilar etanercept (either 25 mg or 50 mg) for their medical condition.
排除标准
- •No strict exclusion criteria were applied.
研究组 & 干预措施
Autoimmune Arthritis
Patients with autoimmune arthritis, including rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, receiving biosimilar etanercept in real-world settings
干预措施: Etanercept (Drug)
结局指标
主要结局
Safety: incidence of adverse events
时间窗: Throughout the study period (up to 12 months for each patient)
All adverse events, including serious adverse events, are reported using system organ classes and preferred terms of the medical dictionary for regulatory activities (MedDRA Desktop Browser 4.0 Beta).
次要结局
- Pain score(Baseline, 3, 6, 9, and 12 months)
- Health assessment questionnaire (HAQ)-score(Baseline, 3, 6, 9, and 12 months)
- Patient global assessments of disease activity (PGA)(3, 6, 9, and 12 months)
- Physician global assessment of disease activity (PhGA)(3, 6, 9, and 12 months)