Post-Marketing Surveillance (Usage Results Study) of Vedolizumab Subcutaneous Injection in Patients With Ulcerative Colitis or Crohn's Disease in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Unexpected Adverse Events (AEs)
研究概览
简要总结
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have had an in-adequate response with, lost response to, or had too many side effects in response to either conventional therapy or a Tumor Necrosis Factor-alpha (TNF-α) antagonist. This study will observe the side effects and potential benefit to UC and CD participants related to vedolizumab SC treatment with data collection from medical files. There is no treatment involved in this study, this is only an observational review of current collected data relating to adults in South Korea with UC or CD treated with vedolizumab SC.
详细描述
This is a prospective, non-interventional, post-marketing study of adult participants with moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to conventional therapy or a TNF-α antagonist. This study will evaluate the safety and effectiveness of vedolizumab SC in a routine clinical practice setting under real world condition.
This study will enroll approximately 600 participants. The data will be prospectively collected, at the centers and recorded into electronic case report forms (e-CRFs). All participants will be enrolled in a single observational group:
• Participants with UC or CD
This multi-center trial will be conducted in South Korea. The overall time for data collection in the study will be approximately 6 years.
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
- •With moderately to severely active UC or CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-α antagonist
- •With evidence of therapeutic benefit after at least 2 vedolizumab intravenous infusions
排除标准
- •With hypersensitivity such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate to the vedolizumab substance or to any of its excipients
- •With active severe infections such as tuberculosis, cytomegalovirus, sepsis, listeriosis and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML)
- •For whom vedolizumab SC is contraindicated as per product label
结局指标
主要结局
Percentage of Participants With Unexpected Adverse Events (AEs)
时间窗: Up to Week 52
Percentage of Participants With Serious Adverse Drug Reactions (SADRs)
时间窗: Up to Week 52
Percentage of Participants With Adverse Events of Special Interest (AESIs)
时间窗: Up to Week 52
Percentage of Participants With Serious Adverse Events (SAEs)
时间窗: Up to Week 52
Percentage of Participants With Adverse Drug Reactions (ADRs)
时间窗: Up to Week 52
Percentage of Participants With Unexpected ADRs
时间窗: Up to Week 52
次要结局
- Percentage of Participants With UC and CD Who Achieved Mucosal Healing(Up to Week 52)
- Percentage of Participants With UC and CD Who Achieved Clinical Response(Up to Week 52)
- Percentage of Participants With UC and CD Who Achieved Clinical Remission(Up to Week 52)