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    Clinical Trial Results:
    Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment

    Summary
    EudraCT number
    		 2011-000885-36
    Trial protocol
    		 ES  
    Global end of trial date
    17 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Mar 2020
    First version publication date
    14 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    APPRECIA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01564823
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GETECCU
    Sponsor organisation address
    C/Gran Via 81, 5º Dpto. 10, Bilbao (Vizcaya), Spain, 48011
    Public contact
    Clinical trials, GETECCU (Spanish Crohn’s Disease and Ulcerative Colitis Working Group), +34 944278855,
    Scientific contact
    Clinical trials, GETECCU (Spanish Crohn’s Disease and Ulcerative Colitis Working Group), +34 944278855,
    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
    17 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Adalimumab vs. Azathioprine in the prevention of endoscopic relapse (quantified using the Rutgeerts score and defined as an score of 2b, 3 or 4) in Cohn’s disease after 52 weeks of treatment.
    Protection of trial subjects
    The study was in compliance with ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 Metronidazole PO: 250 mg/8h, for 3 months. The severity grading for dyspepsia that may occur in patients treated with metronidazole is left to the investigator's discretion. If the investigator considers the dyspepsia to be mild, treatment will not be adjusted. If it is classified as moderate, the dose of metronidazole will be reduced by half, and if it is considered serious, metronidazole will be discontinued. The appearance of paraesthesia in the hands or feet, as well as any side effects attributable to metronidazole at the discretion of the investigator, will lead to discontinuation of the drug, but the patient will remain in the study.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2012
    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: 91
    Worldwide total number of subjects
    91
    EEA total number of subjects
    91
    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)
    88
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 First randomization/first study treatment administration took place on 22/06/2012 and last randomization/last study treatment administration took place on 03/01/2014. 91 patients were screened; 85 were randomized at 22 sites. 1 patient did not receive the study treatment, so 84 were analyzed.

    Pre-assignment
    Screening details
    		 Signed the IC;Age≥18 years;Patients with Crohn’s disease who have undergone an ileocecal/ileocolic resection (L1 or L3);Surgical reconstruction by ileocolic anastomosis.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Randomisation was centralised and the investigator was blinded to allocation of each patient until enrolment. From then on, this was an open-label study at site.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Azathioprine
    Arm description
    		 Azathioprine: 2.5 mg/kg body weight/day PO throughout the full duration of the Trial
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Azathioprine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Azathioprine: 2.5 mg/kg body weight/day PO throughout the full duration of the Trial

    Arm title
    		 Adalimumab
    Arm description
    		 Adalimumab SC 160 mg followed by 80 mg 2 weeks later and then 40 mg every 2 weeks as maintenance throughout the full duration of the Trial.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab SC 160 mg followed by 80 mg 2 weeks later and then 40 mg every 2 weeks as maintenance throughout the full duration of the Trial.

    Number of subjects in period 1 [1]
    		Azathioprine Adalimumab
    Started
    39
    45
    Completed
    27
    41
    Not completed
    12
    4
         Adverse event, serious fatal
    -
    1
         Physician decision
    2
    1
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    9
    1
         Lost to follow-up
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 7 patients were not analyzed: 6 failure of screening and 1 patient was not treated

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Azathioprine
    Reporting group description
    		 Azathioprine: 2.5 mg/kg body weight/day PO throughout the full duration of the Trial

    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab SC 160 mg followed by 80 mg 2 weeks later and then 40 mg every 2 weeks as maintenance throughout the full duration of the Trial.

    Reporting group values
    		 Azathioprine Adalimumab Total
    Number of subjects
    		 39 45 84
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 37 44 81
        From 65-84 years
    		 2 1 3
    Age continuous
    Units: years
        median (full range (min-max))
    		 37 (20 to 68) 35 (19 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 16 26 42
        Male
    		 23 19 42
    Ethnicity
    Units: Subjects
        Caucasian
    		 36 42 78
        Arab
    		 2 2 4
        Gypsy
    		 1 1 2
    Smoking
    Units: Subjects
        Non smoker
    		 10 13 23
        Former smoker
    		 20 21 41
        Smoker
    		 9 11 20
    Alcohol intake
    Units: Subjects
        Abstemious
    		 18 22 40
        Occasional
    		 20 21 41
        Regular
    		 1 1 2
        Unknown
    		 0 1 1
    Localization of disease
    Units: Subjects
        Ileum
    		 23 26 49
        Ileum + Colon
    		 16 19 35
    Upper urinary tract affections
    Units: Subjects
        Yes
    		 3 2 5
        No
    		 36 43 79
    Perforating disease
    Units: Subjects
        Yes
    		 11 20 31
        No
    		 28 25 53
    Perianal affections
    Units: Subjects
        Yes
    		 8 4 12
        No
    		 31 41 72
    Previous surgery
    Units: Subjects
        Yes
    		 3 3 6
        No
    		 36 42 78
    Phenotypes L
    Units: Subjects
        L1
    		 21 25 46
        L1+L4
    		 2 1 3
        L3
    		 15 18 33
        L3+L4
    		 1 1 2
    Phenotypes B
    Units: Subjects
        No B3
    		 22 23 45
        No B3+p
    		 6 2 8
        B3
    		 9 18 27
        B3+p
    		 2 2 4
    Time of disease
    Between diagnosis and consent inform
    Units: Years
        median (full range (min-max))
    		 4 (0 to 34) 6 (0 to 28) -
    Crohn affected length
    Units: cm
        median (full range (min-max))
    		 32.5 (11 to 100) 25 (9 to 70) -

    End points

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    End points reporting groups
    Reporting group title
    Azathioprine
    Reporting group description
    		 Azathioprine: 2.5 mg/kg body weight/day PO throughout the full duration of the Trial

    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab SC 160 mg followed by 80 mg 2 weeks later and then 40 mg every 2 weeks as maintenance throughout the full duration of the Trial.

    Primary: Endoscopic recurrence

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    End point title
    		 Endoscopic recurrence
    End point description
    Endoscopic recurrence was defined as having an assessment of the Rutgeerts index of 2b or 3 or 4 past 52 weeks. Patients without evaluable images after 52 weeks or early discontinuation were considered as therapy failure.
    End point type
    Primary
    End point timeframe
    After 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    23
    19
        No
    16
    26
    Statistical analysis title
    		 Endoscopic recurrence between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1257
    Method
    		 Chi-squared
    Confidence interval

    Primary: Endoscopic recurrence - PP

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    End point title
    		 Endoscopic recurrence - PP
    End point description
    Endoscopic recurrence was defined as having an assessment of the Rutgeerts index of 2b or 3 or 4 past 52 weeks Per Protocol population (PP): Consisted of randomized patients who toke at least one dose of treatment and they had an evaluation of the primary endpoint (evaluable colonoscopy) at Visit 9 (52 weeks).
    End point type
    Primary
    End point timeframe
    After 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    24 [1]
    37 [2]
    Units: subjects
        Yes
    8
    11
        No
    16
    26
    Notes
    [1] - PPC population
    [2] - PPC population
    Statistical analysis title
    		 Endoscopic recurrence between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    61
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7665
    Method
    		 Chi-squared
    Confidence interval

    Primary: Serious endoscopic recurrence

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    End point title
    		 Serious endoscopic recurrence
    End point description
    It was defined the event serious endoscopic recurrence as having an assessment of the Rutgeerts index of 3 or 4.
    End point type
    Primary
    End point timeframe
    After 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: Subjects
        Yes
    17
    13
        No
    22
    32
    Statistical analysis title
    		 Serious endoscopic recurrence between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1608
    Method
    		 Chi-squared
    Confidence interval

    Primary: Combined endpoint of both endoscopic recurrence and MRI enterography

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    End point title
    		 Combined endpoint of both endoscopic recurrence and MRI enterography
    End point description
    It was also defined the combined endpoint of both endoscopic recurrence and MRI enterography, considering recurrence all patients who had an assessment after 52 weeks either of the Rutgeerts index of 2b, 3 or 4 or the Sailer index of mr2 or mr3.
    End point type
    Primary
    End point timeframe
    After 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    30
    27
        No
    9
    18
    Statistical analysis title
    		 Recurrence by endoscopy or MRI between groups
    Comparison groups
    Adalimumab v Azathioprine
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0977
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Clinical remission in week 52

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    End point title
    		 Clinical remission in week 52
    End point description
    It was defined clinical remission as having Cohn’s Disease Activity Index ≤200.
    End point type
    Secondary
    End point timeframe
    in week 52 of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    25
    38
        No
    2
    0
        Unknown
    12
    7
    Statistical analysis title
    		 Clinical remission between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1687
    Method
    		 Chi-squared
    Confidence interval

    Secondary: MRI enterography recurrence

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    End point title
    		 MRI enterography recurrence
    End point description
    MRI enterography recurrence was defined as having an assessment of the Sailer index of mr2 or mr3 past 52 weeks. Patients without evaluable images after 52 weeks or early discontinuation were considered as therapy failure.
    End point type
    Secondary
    End point timeframe
    After 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    25
    22
        No
    14
    23
    Statistical analysis title
    		 MRI enterography recurrence between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1613
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Requirement of hospitalization

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    End point title
    		 Requirement of hospitalization
    End point description
    End point type
    Secondary
    End point timeframe
    During the 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    4
    9
        No
    35
    36
    Statistical analysis title
    		 Requirement of hospitalization between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2182
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Requirement of surgery

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    End point title
    		 Requirement of surgery
    End point description
    End point type
    Secondary
    End point timeframe
    During the 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    39
    45
    Units: subjects
        Yes
    3
    2
        No
    36
    43
    Statistical analysis title
    		 Requirement of surgery between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6594
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Markers of disease activity: C reactive protein

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    End point title
    		 Markers of disease activity: C reactive protein
    End point description
    End point type
    Secondary
    End point timeframe
    in week 52 of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    27
    40
    Units: mg/L
        arithmetic mean (confidence interval 95%)
    1.84 (1.06 to 2.62)
    4.61 (-0.24 to 9.47)
    Statistical analysis title
    		 C reactive protein between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6513
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Markers of disease activity: Fecal calprotectin

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    End point title
    		 Markers of disease activity: Fecal calprotectin
    End point description
    End point type
    Secondary
    End point timeframe
    in week 52 of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    9
    19
    Units: μg/g
        arithmetic mean (confidence interval 95%)
    99.8 (20.6 to 178.9)
    120.5 (-7.9 to 249.0)
    Statistical analysis title
    		 Fecal calprotectin between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6096
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Markers of disease activity: Erythrocyte sedimentation rate

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    End point title
    		 Markers of disease activity: Erythrocyte sedimentation rate
    End point description
    End point type
    Secondary
    End point timeframe
    in week 52 of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    20
    29
    Units: units
        arithmetic mean (confidence interval 95%)
    13.5 (6.6 to 20.5)
    11.4 (7.9 to 15.0)
    Statistical analysis title
    		 ESR between groups
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    49
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8236
    Method
    		 t-test, 2-sided
    Confidence interval

    Secondary: Quality of life by EuroQoL

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    End point title
    		 Quality of life by EuroQoL
    End point description
    Improvement respect to baseline of quality of life measured by EuroQoL questionnaire
    End point type
    Secondary
    End point timeframe
    week 52 of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    26
    40
    Units: percentage
        arithmetic mean (confidence interval 95%)
    12.1 (3.7 to 20.5)
    13.2 (6.7 to 19.7)
    Statistical analysis title
    		 QoL between treatment
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4951
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Quality of life by SIBDQ

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    End point title
    		 Quality of life by SIBDQ
    End point description
    Improvement respect to baseline of quality of life measured by SIBDQ questionnaire
    End point type
    Secondary
    End point timeframe
    after 52 weeks of treatment
    End point values
    		 Azathioprine Adalimumab
    Number of subjects analysed
    25
    40
    Units: percent
        arithmetic mean (confidence interval 95%)
    17.2 (9.6 to 24.7)
    15.1 (8.2 to 22.0)
    Statistical analysis title
    		 QoL between treatment
    Comparison groups
    Azathioprine v Adalimumab
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6949
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Azathioprine
    Reporting group description
    		 Azathioprine: 2.5 mg/kg body weight/day PO throughout the full duration of the Trial

    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab SC 160 mg followed by 80 mg 2 weeks later and then 40 mg every 2 weeks as maintenance throughout the full duration of the Trial.

    Serious adverse events
    		 Azathioprine Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 39 (10.26%)
    9 / 45 (20.00%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periureteral collection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal hemorrhage
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subocclusive syndrome
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequent bowel movements
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Azathioprine Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 39 (89.74%)
    37 / 45 (82.22%)
    Injury, poisoning and procedural complications
    Seroma
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 45 (8.89%)
         occurrences all number
    1
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 45 (2.22%)
         occurrences all number
    4
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    3
    Leukopenia
         subjects affected / exposed
    4 / 39 (10.26%)
    1 / 45 (2.22%)
         occurrences all number
    10
    1
    Neutropenia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 45 (8.89%)
         occurrences all number
    1
    4
    Pyrexia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 45 (8.89%)
         occurrences all number
    1
    4
    Abdominal distension
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 45 (8.89%)
         occurrences all number
    1
    4
    Abdominal pain
         subjects affected / exposed
    3 / 39 (7.69%)
    6 / 45 (13.33%)
         occurrences all number
    3
    7
    Abdominal pain lower
         subjects affected / exposed
    3 / 39 (7.69%)
    3 / 45 (6.67%)
         occurrences all number
    5
    5
    Rectal haemorrhage
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Nausea
         subjects affected / exposed
    3 / 39 (7.69%)
    0 / 45 (0.00%)
         occurrences all number
    5
    0
    Vomiting
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 39 (2.56%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Eczema
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 45 (8.89%)
         occurrences all number
    2
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 39 (23.08%)
    3 / 45 (6.67%)
         occurrences all number
    9
    3
    Back pain
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 45 (6.67%)
         occurrences all number
    2
    3
    Pain in extremity
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 45 (2.22%)
         occurrences all number
    2
    1
    Limb discomfort
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Apr 2012
    1- Elimination of redundant selection criteria and greater specification of others 2- Specification of the accounting record procedure of the medication in the trial

    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.
    A limitation of our study is the lack of a placebo-controlled arm to assess if the observed benefits depend on the post-operative prophylactic drugs used or on the surgery itself.
    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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