Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Number of Participants who have One or More Adverse Drug Reactions
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 Crohn's disease (CD) patients in the routine clinical setting.
详细描述
The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have CD.
This survey 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 300.
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 CD
- •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 (Genetical Recombination) 300 mg, IV infusion, 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 (Genetical Recombination) (Drug)
结局指标
主要结局
Number of Participants who have One or More Adverse Drug Reactions
时间窗: Up to Week 54
AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Number of Participants who have One or More Adverse Events
时间窗: Up to Week 54
Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Change from Baseline in Crohn's Disease Activity Index (CDAI) Score(Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy))
- Change from Baseline in C-reactive protein (CRP)(Baseline and up to Week 54)
- Percentage of Participants with Clinical Remission(Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy))
- Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy))
- Change from Baseline in Albumin(Baseline and up to Week 54)
- Change from Baseline in White Blood Cell Count(Baseline and up to Week 54)
- Change from Baseline in Lymphocytes(Baseline and up to Week 54)
- Change from Baseline in Hematocrit(Baseline and up to Week 54)
- Change from Baseline in Hemoglobin(Baseline and up to Week 54)
- Percentage of Participants with CDAI-70 Response(Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy))
- Percentage of Participants with CDAI-100 Response(Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy))