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    Clinical Trial Results:
    Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study.

    Summary
    EudraCT number
    		 2013-004781-34
    Trial protocol
    		 ES  
    Global end of trial date
    23 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2018
    First version publication date
    24 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    W13-984
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02148718
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Global Medical Services, AbbVie, 001 800-633-9110,
    Scientific contact
    Maria Belen Garbayo Guijarro, AbbVie, belen.garbayo@abbvie.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
    23 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease
    Protection of trial subjects
    Subject read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2014
    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: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    96
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 100 participants were enrolled in the study; 14 participants did not receive study drug and are excluded from the analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Adalimumab
    Arm description
    		 Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).
    Arm type
    		 Experimental

    Investigational medicinal product name
    adalimumab
    Investigational medicinal product code
    Other name
    Humira, ABT-D2E7
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Adalimumab pre-filled syringe, administered by subcutaneous injection

    Number of subjects in period 1 [1]
    		Adalimumab
    Started
    86
    Completed
    55
    Not completed
    31
         Protocol violation
    26
         Discontinued study prematurely
    5
    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: Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).

    Reporting group values
    		 Adalimumab Total
    Number of subjects
    		 86 86
    Age categorical
    Units: Subjects
    Age continuous
    Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug
    Units: years
        arithmetic mean (standard deviation)
    		 37.73 ± 12.16 -
    Gender categorical
    Intent to Treat (ITT) population: all enrolled participants who received at least 1 dose of study drug
    Units: Subjects
        Female
    		 49 49
        Male
    		 37 37

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).

    Primary: Percentage of Participants With Clinical Response at Day 4

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    End point title
    		 Percentage of Participants With Clinical Response at Day 4 [1]
    End point description
    Clinical response defined as a decrease of at least 3 points in Harvey-Bradshaw Index (HBI) score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
    End point type
    Primary
    End point timeframe
    Day 4
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    		 Adalimumab
    Number of subjects analysed
    86 [2]
    Units: percentage of participants
        number (confidence interval 95%)
    61.63 (50.51 to 71.92)
    Notes
    [2] - Intent to Treat (ITT) population: all enrolled participants who received ≥ 1 dose of study drug
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Response at Week 1

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    End point title
    		 Percentage of Participants With Clinical Response at Week 1
    End point description
    Clinical response defined as a decrease of at least 3 points in HBI score. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Adalimumab
    Number of subjects analysed
    86 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    75.58 (65.13 to 84.20)
    Notes
    [3] - ITT population
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Remission at Weeks 2 and 4

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    End point title
    		 Percentage of Participants With Clinical Remission at Weeks 2 and 4
    End point description
    Clinical remission defined as HBI < 5. The HBI consists of only clinical parameters (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications): The first 3 items are scored for the previous day. Patients with Crohn's disease who scored 3 or less on the HBI are very likely to be in remission. Patients with a score of 8 to 9 or higher are considered to have severe disease.
    End point type
    Secondary
    End point timeframe
    Weeks 2 and 4
    End point values
    		 Adalimumab
    Number of subjects analysed
    86 [4]
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    54.65 (43.55 to 65.42)
        Week 4
    62.79 (51.70 to 72.98)
    Notes
    [4] - ITT population
    No statistical analyses for this end point

    Secondary: European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12

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    End point title
    		 European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Index Score: Change From Baseline to Week 12
    End point description
    The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: 1.The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. 2.The EQ-5D visual analog scale (VAS) is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L Index Score are presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    82 [5]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    0.62 ± 0.22
        Change from Baseline to Week 12
    0.14 ± 0.25
    Notes
    [5] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12

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    End point title
    		 European Quality of Life (EuroQol) 5 Dimensions 3 Levels Questionnaire (EQ-5D-3L) Visual Analog Scale (VAS): Change From Baseline to Week 12
    End point description
    The EQ-5D-3L is a standardized instrument for use as a measure of HRQoL and consists of 2 components: 1.The EQ-5D-3L Index Score has five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) with 3 levels of severity for each dimension ('no problems', 'some problems', and 'extreme problems'). The level of severity reported on each of the EQ-5D-3L dimensions determines a unique health state. Health states are converted into a weighted health state index. These weights lie on a scale on which full health has a value of 1 and dead has a value of 0. 2.The EQ-5D VAS is a 20-cm scale with endpoints labeled "best imaginable health" and "worst imaginable health" anchored at 100 and 0, respectively. A positive change represents an improvement in HRQoL. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    82 [6]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    55.36 ± 18.52
        Change from Baseline to Week 12
    15.37 ± 21.36
    Notes
    [6] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12

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    End point title
    		 Inflammatory Bowel Disease Quality-36 (IBDQ-36) Questionnaire Overall Score: Change From Baseline to Week 12
    End point description
    The IBDQ-36 is used to assess the HRQoL related to bowel symptoms. The IBDQ-36 overall score is calculated as the sum of thirty-six items, each scored on a 1 to 7 likert point scale, and ranges from 7 to 252. The highest score indicates the best HRQoL related to bowel symptoms. A positive change in IBDQ-36 overall score indicates an improvement in HRQoL due to inflammatory bowel disease. Mean Baseline and mean change from Baseline to Week 12 in the EQ-5D-3L VAS are presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    78 [7]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    145.1 ± 35.83
        Change from Baseline to Week 12
    44.72 ± 37.98
    Notes
    [7] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12

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    End point title
    		 Fatigue Impact Scale for Daily Use (D-FIS): Change From Baseline to Week 12
    End point description
    The D-FIS is used to measure the impact of fatigue on the daily lives of persons. The D-FIS overall score was calculated as the sum of eight items, each scored on a 0 to 4 point scale, and ranges from 0 to 32. A higher score indicates a higher impact of fatigue on daily life. A negative change in D-FIS Overall Score means an improvement in HRQoL due to fatigue. Mean Baseline and mean change from Baseline to Week 12 are presented.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    79 [8]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    14.45 ± 8.53
        Change from Baseline to Week 12
    -4.69 ± 8.44
    Notes
    [8] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hemoglobin
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes sedimentation rate (ESR), C-reactive protein (CRP), fecal calprotectin, and coagulation (activated partial thromboplastin time [aPTT], international normalized ratio [INR], and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    84 [9]
    Units: dg/dL
    arithmetic mean (standard deviation)
        Baseline (N-84)
    13.01 ± 1.40
        Change from Baseline to Week 12 (N=79)
    0.27 ± 0.97
    Notes
    [9] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Hematocrit
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    84 [10]
    Units: % volume
    arithmetic mean (standard deviation)
        Baseline (N=84)
    39.47 ± 3.99
        Change from Baseline to Week 12 (N=79)
    0.86 ± 2.79
    Notes
    [10] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Leukocytes, Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils, and Platelets
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    84 [11]
    Units: cellsx10^3/uL
    arithmetic mean (standard deviation)
        Leukocytes Baseline (N=84)
    8.11 ± 3.23
        Leukocytes Change from Baseline to Week 12 (N=79)
    -1.62 ± 2.87
        Neutrophils Baseline (N=84)
    5.61 ± 2.86
        Neutrophils Change from Baseline to Week 12 (N=79
    -1.99 ± 2.87
        Lymphocytes Baseline (N=84)
    1.80 ± 0.94
        Lymphocytes Change from Baseline to Week 12 (N=79)
    0.39 ± 0.76
        Monocytes Baseline (N=84)
    0.50 ± 0.25
        Monocytes Change from Baseline to Week 12 (N=79)
    -0.009 ± 0.219
        Eosinophils Baseline (N=84)
    0.17 ± 0.15
        Eosinophils Change from Baseline to Week 12 (N=79)
    -0.010 ± 0.095
        Basophils Baseline (N=84)
    0.02 ± 0.02
        Basophils Change from Baseline to Week 12 (N=79)
    0.003 ± 0.033
        Platelets Baseline (N=84)
    316.1 ± 90.1
        Platelets Change from Baseline to Week 12 (N=79)
    -40.4 ± 76.4
    Notes
    [11] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Sedimentation Rate (ESR)
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    84 [12]
    Units: mm
    arithmetic mean (standard deviation)
        Baseline (N=84)
    19.49 ± 18.38
        Change from Baseline to Week 12 (N=79)
    -7.48 ± 14.26
    Notes
    [12] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: C-reactive Protein (CRP)
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    85 [13]
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline (N=85)
    11.06 ± 16.2
        Change from Baseline to Week 12 (N=80)
    -7.61 ± 16.4
    Notes
    [13] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fecal Calprotectin
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    74 [14]
    Units: mg/kg
    arithmetic mean (standard deviation)
        Baseline (N=74)
    1550.4 ± 2798.4
        Baseline to Week 12 (N=61)
    -1043.8 ± 2895.3
    Notes
    [14] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Activated Partial Thromboplastin Time (aPTT)
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    85 [15]
    Units: sec
    arithmetic mean (standard deviation)
        Baseline (N=85)
    30.58 ± 3.89
        Change from Baseline to Week 12 (N=79)
    0.76 ± 3.97
    Notes
    [15] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: International Normalized Ratio (INR)
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    85 [16]
    Units: ratio
    arithmetic mean (standard deviation)
        Baseline (N=85)
    1.05 ± 0.06
        Change from Baseline to Week 12 (N=79)
    0.02 ± 0.07
    Notes
    [16] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Fibrinogen
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    85 [17]
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline (N=85)
    374.5 ± 68.17
        Change from Baseline to Week 12 (N=79)
    -43.6 ± 65.7
    Notes
    [17] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12

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    End point title
    		 Percentage of Participants With Clinical Response at Day 4 or Week 12 and Clinical Remission at Week 12
    End point description
    The percentage of participants with clinical response (defined as decrease of at least 3 points in HBI score) at Day 4 or Week 1 and clinical remission (defined as a HBI < 5) at Week 12.
    End point type
    Secondary
    End point timeframe
    Up to Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    86 [18]
    Units: percentage of participants
        number (not applicable)
    58.90
    Notes
    [18] - ITT population
    No statistical analyses for this end point

    Secondary: Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes

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    End point title
    		 Change From Baseline to Week 12 in Analytic Markers of Inflammation: Erythrocytes
    End point description
    Analytic markers of inflammation are hemogram (hemoglobin, hematocrit, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelets), erythrocytes, ESR, CRP, fecal calprotectin, and coagulation (aPTT, INR, and fibrinogen). Mean Baseline and mean change from Baseline to Week 12 for each parameter are presented. N=number of subjects with evaluable data at given time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) and Week 12
    End point values
    		 Adalimumab
    Number of subjects analysed
    84 [19]
    Units: cellsx10^6/uL
    arithmetic mean (standard deviation)
        Baseline (N=84)
    4.37 ± 0.51
        Change from Baseline to Week 12 (N=79)
    0.052 ± 0.308
    Notes
    [19] - All participants in the ITT population with evaluable data
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 20 weeks).
    Adverse event reporting additional description
    TEAEs and TESAEs are defined as any AE or SAE with an onset date after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    		 Participants received adalimumab for 12 weeks (160 mg at Week 0; 80 mg at week 2; then adalimumab 40 mg every other week starting at Week 4).

    Serious adverse events
    		 Adalimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 86 (2.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adalimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 86 (40.70%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    General physical health deterioration
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Weight decreased
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Eye disorders
    Eyelid disorder
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Lacrimation increased
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Presbyopia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal mass
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    5
    Abdominal pain
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Aphthous ulcer
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Crohn's disease
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Haemorrhoids
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Subileus
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 86 (4.65%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Eczema
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Psoriasis
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    4
    Rash
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    2
    Skin lesion
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    4
    Arthritis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Flank pain
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Sacroiliitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Folliculitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Herpes virus infection
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    3
    Influenza
         subjects affected / exposed
    4 / 86 (4.65%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    3 / 86 (3.49%)
         occurrences all number
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Rash pustular
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    2
    Rotavirus infection
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 86 (2.33%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    None reported
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