Adalimumab (Humira) in the treatment of chronic pouchitis

Odense University Hospital0 个研究点目标入组 13 人开始时间: 2011年11月21日最近更新: 2021年8月10日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•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

发起方