Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is the assessment of the efficacy of Ery-Dex (dexamethasone intra-erythrocyte) versus placebo in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids.

Detailed Description
-----------------
The medical treatment of Crohn's disease is still unsatisfactory despite the use of large number of drugs as steroids which cause several side effects after a long-term treatment.Ery-Dex thanks its peculiar way of administration (intra-erythrocyte encapsulation and release at very low doses during 1 month)should dramatically reduce side effects due steroids, which are dose dependent, and provide an alternative for long-term glucocorticoid therapy.

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

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male and female patients; age > 18 years patients with steroid-dependent CD in clinical remission showing a relapse in the last 12 months and in treatment with 10mg of methylprednisone at least patients willing and able to give written informed consent Exclusion Criteria: CD with intestinal sub-occlusion, or suspected abdominal abcess, or active perianal disease or CDAI >150 pts. already on therapy with immunosuppressant agents for less than 4 months pts. receiving Infliximab (or other anti-TNF) in the previous 3 months severe concomitant diseases elective surgery already scheduled at the start of the study chronic use of alcohol; drug addiction pregnant women subjects with contra-indication to the use of steroids investigational treatments in the previous 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ery-dex<br>Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval | Drug: Dexamethasone<br>* 500 mg/20 ml encapsulated in erythrocytes, every month for 12 months<br>* Other names: Ery-dex;|
| Placebo Comparator: Placebo<br>placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval. | Drug: Dexamethasone<br>* 500 mg/20 ml encapsulated in erythrocytes, every month for 12 months<br>* Other names: Ery-dex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients maintaining steroids-free clinical remission (CDAI<150) without surgery for 12 months |  | after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of safety by comparison of treatment emergent AE |  | after 12 months | 
| proportion of patients interrupting the study because of adverse events |  | after 12 months | 
| duration of the period of clinical remission |  | after 18 months | 
| dosing of serum cortisol | basal and following ACTH trigger | after 12 months | 
| evaluation of inflammation indexes (ESR, CRP) |  | after 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chron's disease, dexamethasone, ery-dex, CD