Mirikizumab Therapy is Effective for Patients With Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in clinical activities before and after mirikizumab or vedolizumab treatment.
研究概览
简要总结
The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They were endoscopically active ulcerative colitis patients.
排除标准
- •the presence of a long-term illness, colorectal cancer, or infectious colitis
研究组 & 干预措施
Mirikizumab
When the patients were endoscopically active and pathologically high neutrophil infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2), using Geboes biopsy histology scores they will be administered by mirikizumab.
干预措施: Mirikizumab (Drug)
Vedolizumab
When the patients are endoscopically active and pathologically low neutrophil infiltration in epithelium of the colonic mucosa (Geboes score Grade 3.1), using Geboes biopsy histology scores, they will be administered by vedolizumab.
干预措施: Vedolizumab (Drug)
结局指标
主要结局
Changes in clinical activities before and after mirikizumab or vedolizumab treatment.
时间窗: 2 weeks
Clinical activity is graded using the clinical activity index (0, best - 15, worst).
次要结局
- Changes in endoscopic activities before and after mirikizumab or vedolizumab administration.(2 months)
- Changes in pathological activity(2 months)
研究者
Akira Horiuchi
Chief, Digestive Disease Center
Showa Inan General Hospital