Humira 40 mg/0.8 mL for Subcutaneous Injection - Drug Use Investigation (All Patient Investigation) for Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 7,972
- 试验地点
- 1,723
- 主要终点
- Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
研究概览
简要总结
To clarify the following matters:
- Unknown adverse reactions (especially clinically significant adverse reactions)
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Humira
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients prescribed and treated with Humira are included in this survey.
排除标准
- •Contraindications according to the Package Insert:
- •Patients who have serious infections,
- •Patients who have tuberculosis,
- •Patients with a history of hypersensitivity to any ingredient of Humira,
- •Patients who have demyelinating disease or with a history of demyelinating disease,
- •Patients who have cardiac failure congestive.
结局指标
主要结局
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
时间窗: Week 12
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
时间窗: Week 4
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
时间窗: Week 24
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Total Number of Patients With Adverse Events
时间窗: Baseline to Week 24
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
次要结局
- Physicians' Overall Effectiveness Response Rating(Week 24)