Clinical Study to Assess the Efficacy and Safety of Increased Dose of TA-650 in Patients With Crohn's Disease (CD)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and pharmacokinetics after administration of 10mg/kg TA-650 every 8 weeks to patients with Crohn's disease showing an insufficient response to previous treatment with 5 mg/kg of REMICADE every 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's disease
- •Patients who have relapsed with symptoms associated with Crohn's disease within 8 weeks in spite of maintenance treatment with 5mg/kg REMICADE every 8 weeks, and who are judged to be showing an insufficient response to the previous treatment by their physician
排除标准
- •Severe intestinal strictures (which may have an effect on the number of loose stools or diarrhea or dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy), a diagnosis of short bowel syndrome, or previous stoma surgery
- •The presence of significant internal fistula (possibility that surgery might be needed, etc.) is confirmed
- •A history of a serious infusion reaction to REMICADE
- •Pregnant, lactating, and probably pregnant women
- •Patients who have participated in other trials and have been administered other investigational products within 12 weeks before consent
- •Patients judged to be inadequate to participate in this study by their physician
研究组 & 干预措施
TA-650
干预措施: TA-650 (Drug)
结局指标
主要结局
Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period
时间窗: Increased Dose Period (Week 0 to Week 8)
To confirm the decrease in median CDAI at week 8 by ≥ 50 points compared to the CDAI score at week 0 in the increased dose period. In the indication of CDAI change, decrease in CDAI was expressed by positive numbers. CDAI is a research tool used to quantify the symptoms of patients with Crohn's disease. CDAI scores generally range from 0 to 600 points. Clinical remission = CDAI \< 150 points. Moderate disease = CDAI 220 - 450 points. Severe disease = CDAI \> 450 points.
次要结局
- Antibody to TA-650 Determination(Screening Period (Week 0 to Week 16), Increased Dose Period (Week 0 to Week 40))
- CDAI Change at Each Evaluation Time Point in the Increased Dose Period(Increased Dose Period (every 4 weeks for up to 40 weeks))
- CDAI at Each Evaluation Time Point in the Increased Dose Period(Increased Dose Period (every 4 weeks for up to 40 weeks))
- CDAI Remission Rates at Each Evaluation Time Point in the Increased Dose Period(Increased Dose Period (every 4 weeks for up to 40 weeks))
- Serum Concentration of TA-650 at Each Time Point(Screening Period (every 4 weeks for up to 16 weeks), Increased Dose Period (every 4 weeks for up to 40 weeks), a total of 56 weeks)