Special Drug-Use Surveillance Study on Entyvio for IV Infusion 300 mg [Ulcerative Colitis]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,110
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced at Least One Adverse Events (AEs)
研究概览
简要总结
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
详细描述
The drug being tested in this study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.
This study is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 1,000.
This multi-center observational trial will be conducted in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have moderate or severe active UC
- •Have inadequate response to existing therapies
排除标准
- •Patients with any contraindication for vedolizumab
研究组 & 干预措施
Vedolizumab 300 mg
Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
干预措施: Vedolizumab (Drug)
结局指标
主要结局
Number of Participants Who Experienced at Least One Adverse Events (AEs)
时间窗: Up to Week 54
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Number of Participants Who Experienced at Least One Adverse Drug Reactions
时间窗: Up to Week 54
An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug.
次要结局
- Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab(Week 54)
- Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab(Week 54)
- Change From Baseline in Complete Mayo Scores(Baseline and Week 54)
- Change From Baseline in Partial Mayo Scores(Baseline and Week 54)
- Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score(Baseline and Week 54)