jRCT2080223867已完成3 期
Phase III study of AJM300 in patients with active ulcerative colitis (2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study Ajm300 960 Mg Group: 99 Subjects Placebo Group: 99 Subjects
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 16age old over 至 74age old under（—）
- 性别
- All
入选标准
- •Major Inclusion Criteria
- •Patients diagnosed with moderate ulcerative colitis
- •Patients with inadequate response or intolerant to oral 5-ASA
- •Patients who are capable of providing written informed consent
排除标准
- •Major Exclution Criteria
- •Patients with extensive detachment of mucosa or deep ulcer
- •Patients with oral corticosteroid dependency
- •Patients with a complication of marked reduction of immune function
- •Patients who were clinically suspected to have a complication of infectious enteritis
- •Patients with a history or complication of serious infection within 1 year prior to the day of enrollment
- •Patients with CNS neurological symptoms
- •Patients with the following conditions:
- •Serious heart disease
- •Renal impairment
- •Hepatic impairment
- •Patients with a history of serious drug induced allergy with unknown cause
- •Patients with malignant tumor or those whose treatments were completed in less than 5 years
- •Patients with apparent psychological signs
- •Pregnant women, nursing women, women with suspected pregnancy, women who wish to become pregnant during the period from informed consent through to the end of observation/examination at Week 8, and women who do not consent to the use of appropriate birth control methods.
- •Patients who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc
- •Patients of another clinical study including follow-up observation at the time of informed consent
- •Patients who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol
- •Patients who received investigational drugs in the study of AJM300
- •Patients determined to be ineligible for participation in this study by the investigator or sub-investigator
结局指标
主要结局
-
efficacy -Clinical response rate as defined by the Mayo score -The Mayo score
次要结局
- Percentage of rectal bleeding subscore of 0
- Clinical remission rate as defined by the Mayo score
- Time course of the fecal calprotectin
- Mucosal healing rate
- Complete mucosal healing rate
- The Mayo score
- The fecal calprotectin
研究者
研究点 (1)
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