Back to resultsIntra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease (Crodex)
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring dexamethasone, ery-dex, Chron's disease, CD
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
Sites / Locations
- Policlinico Sant'Orsola
- Ospedale Careggi
- Ospedale Morgagni Pierantoni
- Policlinico Universitario
- Ospedale Cervello
- Complesso Integrato Columbus
- Policlinico Tor Vergata
- Ospedale San Camillo
- A.O. San Donato
- Spitalul Clinic Judetean De Urgenta
- Clinic CIBER EHD
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ery-dex
Placebo
Arm Description
Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval
placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.
Outcomes
Primary Outcome Measures
proportion of patients maintaining steroids-free clinical remission (CDAI<150) without surgery for 12 months
Secondary Outcome Measures
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
basal and following ACTH trigger
evaluation of inflammation indexes (ESR, CRP)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01277289
Brief Title
Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
Acronym
Crodex
Official Title
Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
due to the big difficulty to enrol suitable patients
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Erydel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
dexamethasone, ery-dex, Chron's disease, CD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ery-dex
Arm Type
Experimental
Arm Description
Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Ery-dex
Intervention Description
500 mg/20 ml encapsulated in erythrocytes, every month for 12 months
Primary Outcome Measure Information:
Title
proportion of patients maintaining steroids-free clinical remission (CDAI<150) without surgery for 12 months
Time Frame
after 12 months
Secondary Outcome Measure Information:
Title
evaluation of safety by comparison of treatment emergent AE
Time Frame
after 12 months
Title
proportion of patients interrupting the study because of adverse events
Time Frame
after 12 months
Title
duration of the period of clinical remission
Time Frame
after 18 months
Title
dosing of serum cortisol
Description
basal and following ACTH trigger
Time Frame
after 12 months
Title
evaluation of inflammation indexes (ESR, CRP)
Time Frame
after 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Andriulli, MD
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Sant'Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Ospedale Careggi
City
Firenze
ZIP/Postal Code
50100
Country
Italy
Facility Name
Ospedale Morgagni Pierantoni
City
Forlì
ZIP/Postal Code
57100
Country
Italy
Facility Name
Policlinico Universitario
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Cervello
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
Ospedale San Camillo
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
A.O. San Donato
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Spitalul Clinic Judetean De Urgenta
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Clinic CIBER EHD
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
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