Post-marketing Surveillance to Evaluate the Safety and Effectiveness of Upadacitinib (RINVOQ) in Korean Adult Patients With Ulcerative Colitis or Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 14
- 主要终点
- Percentage of participants who reported the events related to important identified risks/important potential risks/missing information
研究概览
简要总结
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis and Crohn's disease. Adverse events and change in disease activity will be assessed.
Upadacitinib is an approved drug for treating Atopic dermatitis (AD), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), ulcerative colitis (UC), and Crohn's disease (CD). Approximately 600 adult participants who are prescribed Upadacitinib by their physician in accordance with local label will be enrolled in Korea.
Upadacitinib will be administered in accordance with the terms of the local marketing authorization, and treatment of participants will be determined solely by the investigator. Participants in the study will be followed for up to 52 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosis with ulcerative colitis or Crohn's Disease suitable for the treatment with Upadacitinib.
- •Participants prescribed upadacitinib in accordance with the approved local label.
排除标准
- •Participants with any contraindication to Upadacitinib.
- •Participants currently participating in another clinical research not including observational study.
结局指标
主要结局
Percentage of participants who reported the events related to important identified risks/important potential risks/missing information
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported Serious Adverse Event
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of participants who reported unexpected (not reflected in the latest approved label) Adverse Events/Adverse Drug Reaction
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported Serious Adverse Drug Reaction
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported known (labeled) Adverse Drug Reaction
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Percentage of participants who reported non-serious Adverse Event/Adverse Drug Reaction
时间窗: Up to 52 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
次要结局
未报告次要终点