Crohn's DiseasePhase 3CrodexNCT01277289
Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
A Phase 3 study testing Dexamethasone in people with Crohn's Disease, run by Quince Therapeutics S.p.A. at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 3 Jun 2009to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects;
- Age > 18 years;
- Patients with steroid-dependent Crohn's disease, documented in the medical history, having suffered from at least one episode of relapse (CDAI > 150) in the last 12 months. Patients should have been in clinical remission (CDAI < 150) for at least four weeks, on stable therapy with at least 10 mg of methylprednisolone (or equivalent), or been on steroidal tapering after a recent relapse. Patients with intolerance or resistance to AZT/6-MP/MTX were eligible;
- Patients willing and able to give written informed consent.
Who cannot join
- Patients with Crohn's disease with intestinal sub-occlusion, or suspect of abdominal abscess, or with active perianal disease, or with clinically active disease at randomization (CDAI ≥150);
- Patients already on therapy with immunosuppressant agents (AZT, 6-MP, MTX) for less than 4 months;
- Patients having received therapy with infliximab (or other anti-TNF) in the previous 3 months;
- Investigational treatments in the previous 3 months prior to randomization;
- Pregnant women, or women who were not using valid birth-control measures, except those in surgical menopause; breast feeding;
- Non collaborating subjects or those unable to be compliant with the treatment and the study schedules;
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- Severe concomitant diseases such as :
- patients with inadequate "bone marrow reserve": WBC < 3000 /mm3; PLTs < 75000 /mm3; Hb < 8 g/dl
- liver disease with total bilirubin ≥ 3 times the upper limit of normal (ULN), AST (GOT) ≥ 3x ULN, alkaline phosphatase ≥ 3x ULN
- renal disease with serum creatinine ≥ 3 mg/dl
- serious cardiac, allergic, lung, neurological diseases, neoplastic or pre-neoplastic disease
- diseases (other than Crohn's) requiring chronic steroid treatment;
- Elective surgery already scheduled at the start of the study (NB: patients having undergone previous surgery for Crohn's disease could be enrolled, if the patient had fully recovered and had been in remission for at least 4 weeks);
- Chronic use of alcohol; drug addiction;
- Subjects with contra-indication to the use of steroids (i.e. systemic fungal infections);
- Evidence of clostridium difficilis in the stools.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Italy6 sites
Policlinico Sant'Orsola
Bologna, 40138
Ospedale Careggi
Florence, 50100
Ospedale Cervello
Palermo, 90100
Complesso Integrato Columbus
Rome, 00100
Ospedale San Camillo
Rome, 00152
A.O. San Donato
San Donato Milanese, 20097
About this study
Official title: Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
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:
- safety of EryDex
- emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients;
- duration of the period of remission;
- evaluation of the hypophysis-adrenal function;
- study of plasma concentrations of dexamethasone;
- effect of therapy on the metabolism of calcium and on indexes of inflammation;
- assessing the quality of life;
- rate of surgical resection
- evaluation of the indirect costs of care.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Dexamethasone
- Keywords
- dexamethasone, ery-dex, Chron's disease, CD
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ery-dex
500 mg/20 ml encapsulated in erythrocytes, every month for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ery-dex | Experimental | Ery-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | placebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Maintaining Steroids-free Clinical Remission (CDAI<150) Without Surgery for 12 Months
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) < 150. A therapy failure was considered to have occurred in patients with a CDAI score over 150 for > 2 weeks and/or the need for systemic steroids (with / without surgery). Hence, the higher the index, the worse the outcome.
Measured: after 12 months
Secondary outcomes (4)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
This evaluation of safety was made by the comparison of treatment emergent adverse events (TEAE). Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment.
Measured: after 12 months
Percentage of Patients Interrupting the Study Because of Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Measured: after 12 months
Duration of the Period of Steroid-free Clinical Remission
The mean time between the end of the steroid therapy and a confirmed relapse of the disease.
Measured: From end of the steroid therapy to relapse, up to 545 days
Dosing of Serum Cortisol
Levels of serum cortisol were measured at baseline and following Adrenocorticotropic Hormone (ACTH) trigger.
Measured: At Baseline and at the end of the study (18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study start3 Jun 2009
- Primary completion30 Dec 2011
- Study completionJun 2012
Why it stopped: due to the difficulty to enroll suitable patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quince Therapeutics S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angelo Andriulli, MD, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277289
- Sponsor's protocol ID
- Crodex01
- Other IDs
- 2008-007329-38, 2008
- Acronym
- Crodex
- Status last verified
- Dec 2023
- First submitted
- 5 Jan 2011
- Last updated
- 3 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Parallel-group Study of Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
- ClinicalTrials.gov ID
- NCT01277289
- Acronym / sponsor ID
- Crodex / Crodex01
- Conditions
- Crohn's Disease
- Keywords
- dexamethasone, ery-dex, Chron's disease, CD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to the difficulty to enroll suitable patients
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Quince Therapeutics S.p.A.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2009 (actual)
- Primary completion
- 30 Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Posted 3 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- safety of EryDex
- emergence of new adverse effects from steroids or disappearance of those possibly pre-existing in the various subgroups of patients;
- duration of the period of remission;
- evaluation of the hypophysis-adrenal function;
- study of plasma concentrations of dexamethasone;
- effect of therapy on the metabolism of calcium and on indexes of inflammation;
- assessing the quality of life;
- rate of surgical resection
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ery-dex | Experimental | Drug: DexamethasoneEry-dex (dexamethasone sodium phosphate)is administered as intra-erythrocyte drug at monthly interval |
| Placebo | Placebo comparator | Drug: Dexamethasoneplacebo comparator (sodium chloride instead of dexamethasone sodium phosphate) is administered in infusion at monthly interval. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects;
- Age > 18 years;
- Patients with steroid-dependent Crohn's disease, documented in the medical history, having suffered from at least one episode of relapse (CDAI > 150) in the last 12 months. Patients should have been in clinical remission (CDAI < 150) for at least four weeks, on stable therapy with at least 10 mg of methylprednisolone (or equivalent), or been on steroidal tapering after a recent relapse. Patients with intolerance or resistance to AZT/6-MP/MTX were eligible;
- Patients willing and able to give written informed consent.
Key exclusion criteria (16 listed)
- Patients with Crohn's disease with intestinal sub-occlusion, or suspect of abdominal abscess, or with active perianal disease, or with clinically active disease at randomization (CDAI ≥150);
- Patients already on therapy with immunosuppressant agents (AZT, 6-MP, MTX) for less than 4 months;
- Patients having received therapy with infliximab (or other anti-TNF) in the previous 3 months;
- Investigational treatments in the previous 3 months prior to randomization;
- Pregnant women, or women who were not using valid birth-control measures, except those in surgical menopause; breast feeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: Ery-dex500 mg/20 ml encapsulated in erythrocytes, every month for 12 months | Drug | Ery-dex, Placebo |
Primary outcome
Percentage of Patients Maintaining Steroids-free Clinical Remission (CDAI<150) Without Surgery for 12 Months
Time frame: after 12 months
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) < 150. A therapy failure was considered to have occurred in patients with a CDAI score over 150 for > 2 weeks and/or the need for systemic steroids (with / without surgery). Hence, the higher the index, the worse the outcome.
4 secondary outcomes
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: after 12 months
Percentage of Patients Interrupting the Study Because of Adverse Events
Time frame: after 12 months
Duration of the Period of Steroid-free Clinical Remission
Time frame: From end of the steroid therapy to relapse, up to 545 days
Dosing of Serum Cortisol
Time frame: At Baseline and at the end of the study (18 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelo Andriulli, MD principal investigator
Unafilliated
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Crohn's Disease, run by Quince Therapeutics S.p.A. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Romania, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Maintaining Steroids-free Clinical Remission (CDAI<150) Without Surgery for 12 Months (time frame: after 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.