Patients with steroid-dependent Crohn?s Disease MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
Conditions
Interventions
Product Name: dexamethasone sodium phosphate 250 mg/ 10 ml
Product Code: ERY-DEX
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: dexamethasone sodium phosphate
CAS Number: 2392-39-4
Co
Sponsors
ERYDEL S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. male and female patients; 2. age > 18 years, 3. patients with steroid-dependent Crohn?s disease, including patients with intolerance or resistance to AZT/6-MP/MTX, in clinical remission (CDAI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 = 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 Crohn?s) 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the efficacy of ERY-DEX vs placebo in maintaining patients with steroid-dependent Crohn?s disease in clinical remission throughout 12 months without oral steroids.;Primary end point(s): Proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery throughout 12 months.;Secondary Objective: 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. | — |
Countries
Italy, Spain
Outcome results
None listed