Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Crodex01

Primary objective: Assessment of the efficacy of EryDex vs PLACEBO in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids. Secondary objectives: 1. safety of EryDex 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. evaluation of the indirect costs of care.

2009-06-03

2011-12-30

2012-06-01

Terminated

Early phase I

51

Inclusion Criteria: 1. Male and female subjects; 2. Age \> 18 years; 3. Patients with steroid-dependent Crohn's disease, documented in the medical history, having suffered from at least one episode of relapse (CDAI \> 150) in the last 12 months. Patients should have been in clinical remission (CDAI \< 150) for at least four weeks, on stable therapy with at least 10 mg of methylprednisolone (or equivalent), or been on steroidal tapering after a recent relapse. Patients with intolerance or resistance to AZT/6-MP/MTX were eligible; 4. Patients willing and able to give written informed consent. Exclusion Criteria: 1. Patients with Crohn's 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 4 months; 3. Patients having received therapy with infliximab (or other anti-TNF) in the previous 3 months; 4. Investigational treatments in the previous 3 months prior to randomization; 5. Pregnant women, or women who were not using valid birth-control measures, except those in surgical menopause; breast feeding; 6. Non collaborating subjects or those unable to be compliant with the treatment and the study schedules; 7. Severe concomitant diseases such as : 1. patients with inadequate "bone marrow reserve": WBC \< 3000 /mm3; PLTs \< 75000 /mm3; Hb \< 8 g/dl 2. liver disease with total bilirubin ≥ 3 times the upper limit of normal (ULN), AST (GOT) ≥ 3x ULN, alkaline phosphatase ≥ 3x ULN 3. renal disease with serum creatinine ≥ 3 mg/dl 4. serious cardiac, allergic, lung, neurological diseases, neoplastic or pre-neoplastic disease 5. diseases (other than Crohn's) requiring chronic steroid treatment; 8. Elective surgery already scheduled at the start of the study (NB: patients having undergone previous surgery for Crohn's disease could be enrolled, if the patient had fully recovered and had been in remission for at least 4 weeks); 9. Chronic use of alcohol; drug addiction; 10. Subjects with contra-indication to the use of steroids (i.e. systemic fungal infections); 11. Evidence of clostridium difficilis in the stools.

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2024-06-03