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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erydel
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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