Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Drug Reactions (ADRs)
研究概览
简要总结
To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 rheumatoid arthritis who started treatment with this drug
- •Patients who received this drug for the first time after the day of launch of this drug.
排除标准
- 未提供
研究组 & 干预措施
Infliximab [infliximab biosimilar 3]
Patients with Rheumatoid Arthritis treated by Infliximab BS
干预措施: Infliximab [infliximab biosimilar 3] (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions (ADRs)
时间窗: 30 weeks from the day of initial dose
An ADR was a treatment-related adverse event, and any untoward medical occurrence attributed to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] in a participant who received this drug. A serious ADR was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; and congenital anomaly/birth defect. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed.
次要结局
- Change in Disease Activity Score Based on 28-joint Count and C-reactive Protein (4 Variables) (DAS28 [4/CRP])(30 weeks from the day of initial dose)
- Percentage of Participants With Remission (DAS28 [4/CRP])(30 weeks from the day of initial dose)