Adalimumab (Humira) in the Treatment of Chronic Pouchitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Clinical response on treatment with Adalimumab
研究概览
简要总结
This study wants to investigate the efficiency of biological treatment for chronic pouchitis. Chronic pouchitis is inflammation in a reconstruction after removal of the colon, a pouch. It is examined in patients with ulcerative colitis.
The primary objective evaluation is to evaluate the clinically effect of biological therapy (adalimumab) in patients with chronic pouchitis.
Secondary objective is to evaluate the effect of biological therapy on the endoscopical and histological inflammatory activity.
It is a double-blinded randomized placebo controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Operated with proctocolectomy and construction of an IPAA
- •Prior to surgery diagnosed with ulcerative colitis according to established clinically, radiologic, endoscopic and histological criteria.
- •Diagnosed with chronic pouchitis as defined above
- •PDAI ≥ 7, with the clinically part of PDAI >2 and the endoscopic part of PDAI >3
- •Age >18 years
- •Negative stool cultures for bacterial bowel pathogens and negative stool microscopy for parasites
- •Serology negative for chronic hepatitis B
- •Negative examination for tuberculosis (including x-ray of thorax and a interferon gamma test)
- •Signed informed consent
排除标准
- •Treatment with glucocorticoids within the last 4 weeks
- •Diagnosed with Crohn's disease
- •Need of an interpreter or if patients do not understand oral or written information.
- •Surgical complications as anal stenosis, leak of the anastomosis, or fistula arising from the pouch
- •Abuse of medicine, alcohol or drugs
- •Ongoing treatment with NSAID (non steroid anti inflammatory drug)
- •Pregnancy or nursing
- •A diverting stoma
- •Malignancy or other severe chronic disease or expected longevity less than one year
- •Patients diagnosed with immune deficiency
- •Ongoing infectious disease
- •Contraindications against treatment with tumor necrosis factor-alpha antibody, such as heart disease, former cancer disease, in vivo vaccination within the last 4 weeks
研究组 & 干预措施
Adalimumab
Every second week, mg: 160-80-40-40-40-40 12 weeks in all
干预措施: Adalimumab (Drug)
Placebo
Given as the active comparator, every second week
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical response on treatment with Adalimumab
时间窗: 12 weeks
The number of patients with chronic pouchitis achieving a clinical improvement, defined as a reduction in clinically PDAI ≥ 2 at any time within the 12 weeks of treatment with adalimumab (Humira). Clinical PDAI (0-6 points)(pouchitis disease activity index)refers to fewer (0-1 point), number of bowel movements(0-2 points), rectal bleeding(0-1 point) and fecal urgency(0-2 points).
次要结局
- Clinical improvement after 12 weeks of treatment(12 weeks)
- Clinical remission after 12 weeks(12 weeks)
- Endoscopic and histologic response after treatment with Adalimumab(12 weeks)
研究者
Mie Dilling Kjaer
Principal investigator
Odense University Hospital