Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Crohn's Disease or Ulcerative Colitis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Drug Reactions
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 Crohn's disease or ulcerative colitis under actual status of use.
详细描述
This study will be conducted with all-case investigation system in patients with Crohn's disease or ulcerative colitis.
This study will be conducted in patients who used this drug after the day of approval of dosage and administration for Crohn's disease or ulcerative colitis at contracted medical institutions. Patients who used this drug before conclusion of the contract with the medical institution will also be included in this study (retrospective patients will be included).
Therefore, Time Perspective is retrospective and prospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's disease or ulcerative colitis who started treatment with this drug
- •Patients who received this drug for the first time at the medical institution 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 Crohn's Disease or Ulcerative Colitis 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
时间窗: 30 weeks from the day of initial dose
An adverse drug reaction (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. Relatedness to Infliximab BS for I.V. Infusion 100mg \[Pfizer\] \[Infliximab Biosimilar 3\] was assessed by the physician.
次要结局
- Percentage of Participants With Remission (Crohn's Disease Activity Index [CDAI]) for Crohn's Disease(Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.)
- Percentage of Participants With Improvement the Crohn's Disease Activity Index for Crohn's Disease(Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.)
- Percentage of Participants With Remission (Partial Mayo) Score for Ulcerative Colitis(Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.)
- Percentage of Participants With Improvement (Partial Mayo) Score for Ulcerative Colitis(Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.)
- Change of Mayo Score From Baseline to Study Completion Date for Ulcerative Colitis(Baseline, Study comnletion date which is the day of visit immediately after 8 weeks have elapsed since the last dose during the observation period.)