JPRN-UMIN000042855已完成未知
A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis - A clinical study to evaluate endoscopic changes and changes in intestinal environment induced by vedolizumab IV by linked color imaging in Japanese patients with ulcerative colitis
Kyoto Prefectural University of Medicine Department of Molecular Gastroenterology and Hepatology0 个研究点目标入组 60 人开始时间: 2021年1月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •[All subjects] 1.Subjects with a history of extensive colonic resection, subtotal or total colectomy 2.Subjects with a history of ileostomy, colostomy, or symptomatic intestinal stricture [Subjects with UC] 1.Subjects with UC that are classified as predominant proctitis 2.Subjects who had received any of the following drugs within the designated period prior to the initial administration of vedolizumab: infliximab (8 weeks), adalimumab (2 weeks), golimumab (4 weeks), tofacitinib (1 week), and ustekinumab (8 weeks) 3.Subjects with prior exposure to vedolizumab, natalizumab, efalizumab or anti-CD20 antibodies (e.g., rituximab, ofatumumab and obinutuzumab) 4.Subjects with any evidence of an active infection within 1 month prior to the first administration of vedolizumab 5.Subjects previously diagnosed as having PML or subjects with symptoms suggestive of PML 6.Subjects with concurrent malignancies who are deemed unsuitable for enrollment by the investigator (e.g., Eastern Cooperative Oncology Group performance status of 2 or more, or are receiving cytotoxic chemotherapy, molecularly targeted therapy, or immune checkpoint inhibitors) 7.Subjects with a history of hypersensitivity reaction to vedolizumab or its components (subjects with contraindication in the vedolizumab package insert) 8.Subjects who are pregnant, are susceptible to being pregnant, are planning to be pregnant, or are lactating [Subjects without UC] 1.Subjects with inflammatory bowel diseases, autoimmune disorders or connective tissue diseases
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