NCT04129723撤回不适用
Stopping Biological Therapy in Perianal Crohn's Disease Patients With Radiologically Healed Fistulas: a Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of perianal Crohn's disease relapse within 12 months after stopping
研究概览
简要总结
The purpose of this which studied the biological therapy can be safely withdrawn in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis.
详细描述
This clinical trial in perianal Crohn's disease patients with radiologically healed fistula on MRI pelvis which studied the biological therapy can be safely withdrawn.
The primary endpoint is clinical relapse at 12 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Have a confirmed diagnosis of perianal Crohn's disease according to established clinical, endoscopic, radiological and histologic criteria
- •On biological therapy (anti-tumour necrosis factor, anti-integrin, anti-IL12/23) for at least 6 months
- •Confirmation of radiologically healed perianal Crohn's fistulas on MRI pelvis within the past 12 months by experienced radiologists
- •In steroid-free clinical remission for at least 6 months with fecal calprotectin <250 μg/g
- •Stable doses of immunosuppressants for at least 3 months if immunosuppressants are used
- •Written informed consent
排除标准
- •History of severe acute or delayed infusion reaction to biological therapy
- •Fistulising Crohn's disease to organs other than perianal Crohn's fistula (fistulation to skin, intestines, bladder etc.)
- •Prior history of diverting ileostomy, colostomy, proctocolectomy or proctectomy
- •Known pregnancy
- •Terminal illness
结局指标
主要结局
Rate of perianal Crohn's disease relapse within 12 months after stopping
时间窗: 12 months
Relapse rate of patient will be calculated
次要结局
- Efficacy of re-treatment with biological therapy after luminal Crohn's disease relapse(12 months)
- Factors associated with relapse of perianal Crohn's disease after stopping biological therapy(12 months)
- Rate of luminal Crohn's disease relapse within 12 months after stopping biological therapy(12 months)
- Factors associated with relapse of luminal Crohn's disease after stopping biological therapy(12 months)
研究者
Mak Wing Yan
Assistant Professor
Chinese University of Hong Kong
研究点 (1)
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