An Observational Study Designed to Investigate the Utilisation and Effectiveness of Originator and Biosimilar Anti-TNF Agents in Australian Rheumatology
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 22
- 主要终点
- Disease activity score based on a 28 joint count (DAS28)
研究概览
简要总结
An observational study investigating the utilisation and effectiveness of originator and biosimilar anti-TNF agents in patients with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.
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
- •Patients with a confirmed diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS) who are being treated at a participating OPAL clinic.
排除标准
- 未提供
结局指标
主要结局
Disease activity score based on a 28 joint count (DAS28)
时间窗: 3 years
Comparative assessment of disease activity as measured by DAS28 in patients receiving originators vs biosimilars. Higher DAS28 scores indicate more severe disease activity.
Health Assessment Questionnaire Disability Index (HAQ-DI)
时间窗: 3 years
Comparative assessment of disease impact on quality of life and daily physical functions in patients receiving originators vs biosimilars. HAQ-DI is designed to measure impact on everyday life. Higher scores indicate more severe disability.
次要结局
- Number of patients discontinuing the drug for safety reasons(3 years)
- 36-item Short Form Health Survey (SF-36)(3 years)
- Patient Health Questionnaire-2 (PHQ-2)(3 years)
- Fatigue assessed by the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire(3 years)