E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with steroid-dependent Crohns Disease |
|
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 |
Assessment of the efficacy of ERY-DEX vs placebo in maintaining patients with steroid-dependent Crohns disease in clinical remission throughout 12 months without oral steroids. |
|
E.2.2 | Secondary objectives of the trial |
1.safety of ERY-DEX; 2. emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients; 3. duration of the period of remission; 4. evaluation of the hypophysis-adrenal function; 5. study of plasma concentrations of dexamethasone; 6. effect of therapy on the metabolism of calcium and on indexes of inflammation; 7. assessing the quality of life; 8. rate of surgical resection; 9. indirect costs of care. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. male and female patients; 2. age > 18 years, 3. patients with steroid-dependent Crohns disease, including patients with intolerance or resistance to AZT/6-MP/MTX, in clinical remission (CDAI < 150) for at least 4 weeks after a fixed schedule of methylprednisolone tapering; 4. patients willing and able to give written informed consent. |
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E.4 | Principal exclusion criteria |
1)patients with Crohns disease with intestinal sub-occlusion, or suspect of abdominal abscess, or with active perianal disease, or with clinically active disease at randomization (CDAI > 150); 2) patients already on therapy with immunosuppressant agents (AZT, 6-MP, MTX) for less than 6 months; 3) patients having received therapy with infliximab in the previous 3 months; 4)investigational treatments in the previous 3 months since the randomization; 5) pregnant women, or women who are not using valid birth-control measures, except those in surgical menopause; breast feeding women; 6) non collaborating subjects or unable to be compliant with the treatment and the study schedules 7) severe concomitant diseases such as : (a)patients with inadequate bone marrow reserve: WBC < 3000 /mm3; PLTs < 75000 /mm3; Hb < 10 gr/dl; (b) liver disease with total bilirubin >= 3 times the upper limit of normal (ULN), AST (GOT) >= 5 ULN, alkaline phosphatase >= 5 ULN; (c) renal disease with serum creatinine >= 3 mg/dl; (d) serious cardiac, allergic, lung, neurological diseases, neoplastic or pre-neoplastic disease; (e) diseases (other than Crohns) requiring chronic steroid treatment; 8)Elective surgery already scheduled at the start of the study; 9)Chronic use of alcohol, drug addiction; 10) Subjects with contra-indication to the use of steroids (i.e. systemic fungal infections). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery throughout 12 months. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Valutazione parametri qualita` di vita |
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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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
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
|
Gravi motivi di safety. Superiorita` significativa alla interim analysis, o manifesta inefficacia del trattamento sperimentale. |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |