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

Condition(s) targeted: Crohn's Disease

Intervention: Dexamethasone (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Erydel

Official(s) and/or principal investigator(s):
Angelo Andriulli, MD, Principal Investigator, Affiliation: Unafilliated

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: proportion of patients maintaining steroids-free clinical remission (CDAI<150) without surgery for 12 months

Secondary outcome:

evaluation of safety by comparison of treatment emergent AE

proportion of patients interrupting the study because of adverse events

duration of the period of clinical remission

dosing of serum cortisol

evaluation of inflammation indexes (ESR, CRP)

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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Policlinico Sant'Orsola, Bologna 40138, Italy

Ospedale Careggi, Firenze 50100, Italy

Ospedale Morgagni Pierantoni, Forlì 57100, Italy

Policlinico Universitario, Padova 35128, Italy

Ospedale Cervello, Palermo 90100, Italy

Complesso Integrato Columbus, Rome 00100, Italy

Ospedale San Camillo, Rome 00152, Italy

Policlinico Tor Vergata, Rome 00133, Italy

A.O. San Donato, San Donato Milanese 20097, Italy

Spitalul Clinic Judetean De Urgenta, Cluj-Napoca 400006, Romania

Clinic CIBER EHD, Barcelona 08036, Spain

Starting date: April 2009
Last updated: September 18, 2012