Biological therapy in the prevention of Crohn`s disease recurrence after resection in ileocecal region.

niveristy Hospital Na Bulovce0 个研究点目标入组 50 人开始时间: 2009年1月5日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•- Suitable patients for the study are all patients admitted for surgery due to ileocecal Crohn's disease, who have never been treated by any biological therapy (naive)
•- age 18-65years
•- no signs of system infection (viral hepatitis)
•- negative chest X-ray and Quantiferron test for TBC
•- no signs of heart failure
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- psychical inability to uderstand the instructions and signing of the informed consent
•- pregnant or lactating females, or females who intend to get pregnant within 1 year
•- patients with known allergy to Infliximab
•- residual bowel disease (except perianal form) or after multiple resections, strictureplasty or with ostomy
•- used biological therapy before
•- signs of viral hepatitis
•Further exclusion criteria
•- adverse events after study medication
•- patients with postoperative complications prolonging hospitalization for more than 2 weeks
•- different perioperative finding - residual bowel disease (except perianal form)
•- different surgical procedure (stricturoplasty, ostomy)
•- protocol failure
•- patient refuses further participation in the study
•- findings of malignancy
•The criteria of premature termination of prophylaxis
•- signs of recurrence of Crohn's disease (increase CDAI of 75pts, endoscopic score >2, need of reoperation)

发起方

niveristy Hospital Na Bulovce