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    Clinical Trial Results:
    Multicenter, randomized, double-blind, parallel-group study of intra-erythrocyte dexamethasone versus placebo in patients with steroid-dependent Crohn's disease

    Summary
    EudraCT number
    2008-007329-38
    Trial protocol
    IT   ES  
    Global end of trial date
    30 Dec 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CRODEX01
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01277289
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Erydel S.p.A.
    Sponsor organisation address
    Via Meucci, 3, Bresso (MI), Italy, 20091
    Public contact
    Clinical Trial Transparency Manager, Erydel S.p.A., +39 0236504470, info@erydel.com
    Scientific contact
    Clinical Trial Transparency Manager, Erydel S.p.A., +39 0236504470, info@erydel.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Dec 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Assessment of the efficacy of Ery-Dex vs placebo in maintaining patients with steroid-dependent Crohn's disease in clinical remission throughout 12 months without oral steroids.
    Protection of trial subjects
    This study was conducted in accordance with the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Jun 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    Italy: 49
    Country: Number of subjects enrolled
    Romania: 1
    Worldwide total number of subjects
    51
    EEA total number of subjects
    51
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    44
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    There were 63 patients enrolled into the screening phase at 10 sites; of these, 51 patients (representing the Safety population) were randomized at 9 sites.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was a multicenter, randomized, double-blind, PLACEBO-controlled, parallel-group study comparing EryDex versus PLACEBO.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    EryDex
    Arm description
    EriDex (dexamethasone sodium phosphated administered as intra-erythrocyte drug at monthly intervals for 12 months).
    Arm type
    Experimental

    Investigational medicinal product name
    EriDex
    Investigational medicinal product code
    Other name
    dexamethasone sodium phosphate for encapsulation in human erythrocytes
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dexamethasone sodium phosphate encapsulated in human erythrocytes (EryDex): vials of 250 mg / 10 ml Monthly administration of EryDex (500 mg / 2 vials) for 12 administrations (12 months). 50 ml of “encapsulated” erythrocytes (previously taken from the same patient) after conditioning with Dexamethasone Sodium Phosphate (500 mg in 20 ml).

    Arm title
    Placebo comparator
    Arm description
    Placebo comparator (administered as intra-erythrocyte drug at monthly intervals for 12 months).
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Monthly administration of Placebo for 12 administrations (12 months). Placebo (10 ml NaCl, 0.372%).

    Number of subjects in period 1
    EryDex Placebo comparator
    Started
    28
    23
    Completed
    5
    2
    Not completed
    23
    21
         Consent withdrawn by subject
    1
    1
         Physician decision
    1
    -
         Fragile vein
    1
    -
         Adverse event, non-fatal
    2
    1
         Violation
    1
    1
         Premature closure of the study
    4
    2
         Therapy failure and/or Crohn's surgery
    13
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    EryDex
    Reporting group description
    EriDex (dexamethasone sodium phosphated administered as intra-erythrocyte drug at monthly intervals for 12 months).

    Reporting group title
    Placebo comparator
    Reporting group description
    Placebo comparator (administered as intra-erythrocyte drug at monthly intervals for 12 months).

    Reporting group values
    EryDex Placebo comparator Total
    Number of subjects
    28 23 51
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    47.3 ± 14.9 43.4 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    20 7 27
        Male
    8 16 24

    End points

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    End points reporting groups
    Reporting group title
    EryDex
    Reporting group description
    EriDex (dexamethasone sodium phosphated administered as intra-erythrocyte drug at monthly intervals for 12 months).

    Reporting group title
    Placebo comparator
    Reporting group description
    Placebo comparator (administered as intra-erythrocyte drug at monthly intervals for 12 months).

    Primary: Proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery throughout 12 months

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    End point title
    Proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery throughout 12 months [1]
    End point description
    The primary efficacy end-point is the proportion of patients maintaining steroid-free clinical remission (CDAI < 150) without surgery. The number of patients completing the 12 months of the study was low (n=51); therefore, only a descriptive analysis was performed. No statistical analyses were performed for the secondary end-points because of the early study termination.
    End point type
    Primary
    End point timeframe
    12 months since the day of the first infusion.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The number of patients completing the 12 months of the study was low (n=51); therefore, only a descriptive analysis was performed.
    End point values
    EryDex Placebo comparator
    Number of subjects analysed
    28
    23
    Units: percentage
        number (not applicable)
    17.9
    8.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At days 15, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 (follow up), 420 (follow up) and 600 (follow up).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12
    Reporting groups
    Reporting group title
    EriDex - Safety set
    Reporting group description
    -

    Reporting group title
    Placebo - Safety set
    Reporting group description
    -

    Serious adverse events
    EriDex - Safety set Placebo - Safety set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 28 (21.43%)
    4 / 23 (17.39%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Spinal fracture
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 23 (13.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Staphylococcal infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.5%
    Non-serious adverse events
    EriDex - Safety set Placebo - Safety set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 28 (60.71%)
    15 / 23 (65.22%)
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 28 (21.43%)
    4 / 23 (17.39%)
         occurrences all number
    7
    5
    Hyperpyrexia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Irritability
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 23 (8.70%)
         occurrences all number
    6
    2
    Oedema
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Influenza
         subjects affected / exposed
    4 / 28 (14.29%)
    4 / 23 (17.39%)
         occurrences all number
    4
    7
    Pharyngolaryngeal pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Insomnia
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 23 (13.04%)
         occurrences all number
    5
    3
    Investigations
    Blood iron decreased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Haematocrit decreased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Red blood cell count decreased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Weight increased
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 23 (13.04%)
         occurrences all number
    0
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Anaemia macrocytic
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 23 (13.04%)
         occurrences all number
    1
    3
    Leukocytosis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Neutrophilia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Ocular hypertension
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 23 (4.35%)
         occurrences all number
    3
    1
    Acetonaemic vomiting
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Anal fistula
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Crohn's disease
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 23 (4.35%)
         occurrences all number
    2
    1
    Dyspepsia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Faecal incontinence
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Faeces discoloured
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal reflux disease
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    10
    Haematochezia
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Intestinal obstruction
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 23 (8.70%)
         occurrences all number
    3
    2
    Rectal tenesmus
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Subileus
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 23 (8.70%)
         occurrences all number
    1
    2
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Erythema
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Skin striae
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Pollakiuria
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    Renal colic
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    5 / 28 (17.86%)
    0 / 23 (0.00%)
         occurrences all number
    5
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Back pain
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 23 (4.35%)
         occurrences all number
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Infections and infestations
    Ear infection
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Herpes zoster ophthalmicus
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2008
    - change of exclusion criteria re: hemoglobin (Hb < 8 gr/dl, instead of Hb < 10 gr/dl) and liver enzymes (AST [GOT] ≥3x ULN and alkaline phosphatase ≥3x ULN, instead of ≥5x ULN for both parameters) - washout from previous immunosuppressants reduced from 6 to 4 months - the exclusion of subjects with prior therapy based on anti-TNF within 3 months of the enrolment was specified - the “Clostridium difficilis” stool test was introduced at baseline - antibiotics were permitted only if necessary because of infections and for not longer than 15 days. The use of antibiotics as specific therapy for Crohn’s Disease was not allowed - follow-up prolonged up to 6 months to check eventual relapse of disease in patients completing the study - patient’s diary completion extended from 7 days to the entire month between treatments - SF 36 questionnaire on quality of life was added - ICF was updated accordingly - an additional ICF was introduced to collect long-term health-related information, in particular relapses, in patients withdrawing the consent to the general study
    20 Jul 2009
    - additional samples were requested for dexamethasone dosing in infusion bags from visit 4 to visit 11 to check stable dosing and correct encapsulation procedures in the long term; blood would be taken directly from the infusion bag; no additional venipuncture needed - definition of resistance to AZT/6-MP/MTX corrected, because of a typing error, to stay in line with international guidelines (inability to suspend steroids after at least 4 months of AZT/6-MP/MTX treatment at appropriate dosage; instead of 6 months) - other typing errors were corrected - specifications added in the labeling of tubes for the plasma dexamethasone concentrations - ICF was updated accordingly
    22 Jun 2010
    - change in the screening and identification of patients suitable for study (without changing the target patient population): allowed inclusion of subjects with at least one episode of relapse (CDAI > 150) in the last 12 months, in clinical remission (CDAI < 150) for at least four weeks, and on stable therapy with at least 10 mg of methylprednisolone (or equivalent) for at least 2 weeks - ICF was updated accordingly - reference to the already approved change of the Coordinating Investigator - change in the name of the CRO following the study - change in the number of participating sites (up to 15 in total) - end of patients’ enrolment: extended to December 2011 - minor, non substantial, changes to provide clarifications on issues that emerged and were discussed during the course of the study, without changes in the study conduct

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No limitations or caveats are applicable to this summary of results.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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