JPRN-jRCT1080225363已完成Unknown
Clinical effectiveness and safety of intravenous vedolizumab in Japanese patients with ulcerative colitis: a real-world multicentre retrospective cohort study in tertiary hospitals.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 370
研究概览
简要总结
This study showed the efficacy and safety of Vedolizumab in the introduction and maintenance phases for patients with ulcerative colitis administered to Vedolizumab.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1. Patient initiated VDZ IV treatment (at least one infusion) as per label indication in Japan between December 1st, 2018 and February 29th, 2020
- •2. Female or male patient with a confirmed diagnosis of moderately to severely active UC
- •3. Patient aged 20 years or older at index event
- •4. Patient has medical information available from the date of UC diagnosis
排除标准
- •1. Patient that received VDZ IV as part of clinical trial or interventional clinical study at index event
- •2. Patient enrolled in another Inflammatory Bowel Disease (IBD) clinical trial or interventional clinical study at index event
- •3. Partial Mayo score is missing at baseline
- •4. Patient initiated VDZ IV treatment as combination therapy with another biologic agent
- •5. Patient initiated VDZ IV treatment at another institution (patient's medical information is not precisely accessible)
- •6. Patient requested to opt-out of his or her medical information
研究者
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