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

Phase 1

• Conditions: Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).; MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease

• Registration Number: EUCTR2008-005688-32-CZ
• Lead Sponsor: niveristy Hospital Na Bulovce

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-05
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- 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

Exclusion Criteria

- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of the prospective randomized placebo controlled study is to prove the efficacy of biological therapy (Infliximab) in prevention of Crohn's disease recurrence in 24 months (defined as endoscopic recurrence - in endoscopic score of i2 or more) after surgery in ileocecal region;Secondary Objective: Secondary aim is to compare the rate of clinical relapse in both groups (defined as a increase in CDAI score of 75 points). To design algorithm of disease recurrence monitoring in terms of multi specialty cooperation (surgeon, gastroenterologist, radiologist, immunologist) using new non-invasive techniques (biological markers, biochemistry markers, NMR- enterography, ultrasound) including calculation of costs.;Primary end point(s): incidence of endoscopic recurrence in 24 months after surgery, rate of clinical relapse, risk factors for development of recurrence, quality of life, incidence of repeated hospitalization eventually another surgery