E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The primary objective of the study is to assess the intermediate effects of infliximab on the inflammatory components of the MRI enteroclysis score of severity in Ileal Crohn’s Disease (MICD, see 20.) in patients with Crohn’s disease. |
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E.2.2 | Secondary objectives of the trial |
The major secondary objectives include: 1. The short term effects of infliximab on MICD 2. The effects of infliximab on the individual components of the MICD score and on the total score classifying the severity of inflammation and obstructive disease 3. The effect of infliximab on disease activity and quality of life from day 1 after the first infusion 4. Validation of the MRI enteroclysis scoring system
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men and women ≥ 18 and ≤ 65 years of age, - Are capable of understanding and signing an informed consent - Are considered eligible according to the following tuberculosis (TB) screening criteria, - The presence of active disease (CDAI > 220, CRP > 10 mg/L), - ...
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E.4 | Principal exclusion criteria |
- Have a medical contraindication for MRI enteroclysis, - Use more than 15 mg of oral steroids (prednisone or equivalent) within the 2 weeks prior to baseline MRI. IV use of steroids is not allowed within that same period, - Have a severe prestenotic dilation of the ileum on screening MRI (severe dilation is defined as > 2 times the luminal diameter of the unaffected ileum), - Have had bowel resection of > 100 cm, - Person with no social insurance, - Have presence of an abdominal abscess, - Have MRI enteroclysis confirmed internal fistula, - Be considered ineligible according to the tuberculosis criteria, - Have non conform screening laboratory tests results, - Active participation in another clinical trial or having been included in a clinical trial until 3 months before screening, - ... |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the number of patients achieving a clinically significant change in MRI enteroclysis inflammatory sub-scores of severity in Ileal Crohn’s Disease (MICD); defined as an improvement of at least 2 points and at least 50% on the inflammatory subscores. i.e. 4 to 2 or 5 to 2 or 8 to 4, as measured with contrast enhanced MRI enteroclysis at week 26 compared to baseline. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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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The end of the trial is defined by the inclusion duration added with duration of the post inclusion follow up of the last included patient and the duration of the analysis. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |