Conditions: Crohn's Disease
Keywords: dexamethasone ery-dex Chron's disease CD
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: no

Brief summary:
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.

Detailed description:
This was a multicenter, randomized, double-blind, PLACEBO-controlled, parallel-group study comparing EryDex versus PLACEBO. Patients with steroid-dependent Crohn's disease were enrolled and randomized to undergo 12 infusions of intraerythrocyte dexamethasone (EryDex), or PLACEBO. A balanced (1:1) randomization between the two treatment groups (EryDex / PLACEBO) was employed.

At the time of randomization, study patients were stratified at each study site according to their previous therapy with AZT/6MP/MTX (never treated with AZT/6MP/MTX or intolerant/resistant to the therapy with AZT/6MP/MTX). The treatment was planned to be performed with 12 monthly infusions of EryDex or PLACEBO.

Patients were followed-up after completion of the treatment for 6 months in patients regularly completing the study and 3 months in patients discontinuing from the study prematurely. The evaluation of the primary and secondary objectives was to be done at the 12th month of study (one month after the last study drug infusion), or upon relapse.

Arms:
arm 1: Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval arm 2: placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.

Interventions: intervention 1: Dexamethasone
Intervention descriptions: intervention 1: 500 mg/20 ml encapsulated in erythrocytes, every month for 12 months

Protocol document: