JPRN-jRCT2080223867已完成3 期
Phase III study of AJM300 in patients with active ulcerative colitis (2)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •Major Inclusion Criteria
- •1. Patients diagnosed with moderate ulcerative colitis
- •2. Patients with inadequate response or intolerant to oral 5-ASA
- •3. Patients who are capable of providing written informed consent
排除标准
- •Major Exclution Criteria
- •1. Patients with extensive detachment of mucosa or deep ulcer
- •2. Patients with oral corticosteroid dependency
- •3. Patients with a complication of marked reduction of immune function
- •4. Patients who were clinically suspected to have a complication of infectious enteritis
- •5. Patients with a history or complication of serious infection within 1 year prior to the day of enrollment
- •6. Patients with CNS neurological symptoms
- •7. Patients with the following conditions:
- •-Serious heart disease
- •-Renal impairment
- •-Hepatic impairment
- •8. Patients with a history of serious drug induced allergy with unknown cause
- •9. Patients with malignant tumor or those whose treatments were completed in less than 5 years
- •10. Patients with apparent psychological signs
- •11. 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.
- •12. Patients who are definitely eligible for surgical intervention such as large bowel perforation, major bleeding, and toxic megacolon syndrome, etc
- •13. Patients of another clinical study including follow-up observation at the time of informed consent
- •14. Patients who received another investigational drug within 12 weeks prior to the examinations/observation defined by the protocol
- •15. Patients who received investigational drugs in the study of AJM300
- •16. Patients determined to be ineligible for participation in this study by the investigator or sub-investigator
研究者
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