E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Crohn`s disease recurrence after surgery in ileocecal region by postoperative application of infliximab (four infusions).
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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50 pts will be included, last outpatient control of the last patients (24 months of follow up) in case of new negative information about the IMP, financial reason
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |