E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflammatory Bowel Disease (IBD) complicated by anemia. Patient under anti-TNF alpha therapy |
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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 |
Efficacy of unique intraveinous infusion of Ferrisat® versus placebo to treat iron deficiency anemia associated to IBD (under anti-TNF alpha therapy) |
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E.2.2 | Secondary objectives of the trial |
Evaluation of tolerance of iron intraveinous infusion Follow up of therapeutic response to anti-TNF therapy by scoring CDAI (Crohn’s disease activity index) and Mayo Score Effect on patient's quality of life (IBDQ, SF 36 and FACIT scores)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- AGE GREATER THAN 18 YEARS - IBD DEFINED ACCORDING TO THE USUAL ENDOSCOPIC, HISTOLOGICAL AND RADIOLOGICAL CRITERIA, SINCE MORE THAN 3 MONTHS - PATIENT UNDER ANTI-TNF a TREATMENT OR IN PROGRAMMATION - ANEMIA (<13g/dl FOR MAN OR <12g/dl FOR WOMAN) - FERRITINEMIA <100 - SIGNED INFORM CONSENT
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E.4 | Principal exclusion criteria |
- HISTORY OF ASTHMA, ECZEMA, ATOPIA -FOLATES VALUE < NORMAL VALUE -VITAMIN B12 VALUE < NORMAL VALUE -SEVERE ANEMIA (Definition) -PATIENT WITH ERYTROPOITINE TREATMENT -HYPERSENSIBILITY TO DEXTRAN -KNOWN ALLERGIA TO FERRISAT -DECOMPENSATED CIRRHOSIS -CHRONIC HEPATITIS -INFECTION -RHUMATOID ARTHRITIS -CHRONIC RENAL FAILURE -PARTICPATION TO CLINICAL TRIAL WITHIN THE LAST 3 MONTHS
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E.5 End points |
E.5.1 | Primary end point(s) |
Définition de la réponse au traitement martial intraveineux : Le critère principal de jugement est la correction de l’anémie à la semaine 6. Le critère sera évalué par la réalisation d’une numération formule sanguine. La correction de l’anémie sera définie par les critères OMS soit, une normalisation du taux d'hémoglobine dans le sang avec pour l'homme une valeur supérieure ou égale à 13 g/dL et pour la femme une valeur supérieure ou égale à 12 g/dL
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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 | 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 | 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) | 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 | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 38 |
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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End of the trial per patient = End of the last visit (Week 14) End of the trial = End of the last visit for the last patient included in the trial |
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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 |