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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005688-32-CZ

Enrollment

Registered

2009-01-05

Start date

2009-07-02

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Remicade Pharmaceutical Form: Powder for injection* INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Czech Republic

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026