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    Clinical Trial Results:
    A Phase II, multi-center, double-blind, placebo-controlled, parallel-group, dose-response study to assess the safety and efficacy of CDP870/Certolizumab pegol, dosed subcutaneously in patients with active crohn's disease

    Summary
    EudraCT number
    		 2014-004399-42
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    08 Nov 2007

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Sep 2020
    First version publication date
    11 Jun 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Alignment with final posting on ClinicalTrials.gov after NIH review.

    Trial information

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    Trial identification
    Sponsor protocol code
    C87037
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00291668
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UCB Japan Co., Ltd
    Sponsor organisation address
    Shinjuku-ku, Tokyo, Japan, 160-0023
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 4815 15, clinicaltrials@ucb.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 15, clinicaltrials@ucb.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to estimate the dose response in subjects with active Crohn’s Disease (CD), and to evaluate the efficacy of certolizumab pegol in these subjects.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Steroids, immunosuppressants, antibacterial agents, 5-ASA derivatives, antidiarrheal drugs, topical ano-rectal treatments, and laxative drugs/enemas were allowed concomitantly with no change in dosage and administration from the start of the observation period to Week 6.
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    02 Mar 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 9 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 94
    Worldwide total number of subjects
    94
    EEA total number of subjects
    0
    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)
    6
    Adults (18-64 years)
    88
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study started to enroll subjects in March 2006 and concluded in November 2007.

    Pre-assignment
    Screening details
    		 Participant Flow refers to the Safety Set, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    PBO
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

    Arm title
    		 Certolizumab pegol 200 mg
    Arm description
    		 Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects in the CZP 200 mg arm received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Subjects in the CZP 400 mg arm received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Arm title
    		 Certolizumab pegol 400 mg
    Arm description
    		 Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CZP
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects in the CZP 200 mg arm received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. Subjects in the CZP 400 mg arm received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Number of subjects in period 1
    		Placebo Certolizumab pegol 200 mg Certolizumab pegol 400 mg
    Started
    32
    30
    32
    Completed
    28
    29
    31
    Not completed
    4
    1
    1
         SAE, non-fatal + AE, non-serious, non-fatal
    1
    -
    -
         AE, non-serious, non-fatal
    1
    -
    -
         SAE, non-fatal
    1
    1
    1
         Lack of efficacy
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 200 mg
    Reporting group description
    		 Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 400 mg
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Reporting group values
    		 Placebo Certolizumab pegol 200 mg Certolizumab pegol 400 mg Total
    Number of subjects
    		 32 30 32 94
    Age categorical
    Units: Subjects
        <=18 years
    		 2 2 2 6
        Between 18 and 65 years
    		 30 28 30 88
        >=65 years
    		 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.6 ( 8.16 ) 32.7 ( 9.34 ) 31.4 ( 8.27 ) -
    Gender Categorical
    Units: Subjects
        Male
    		 26 22 25 73
        Female
    		 6 8 7 21

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 200 mg
    Reporting group description
    		 Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 400 mg
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Subject analysis set title
    Full Analysis Set (Placebo treated subjects)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: - Subjects with Good Clinical Practice (GCP) violations - Subjects who were not diagnosed (definitely) with Crohn’s Disease - Subjects who received no dose of study medication - Subjects with no data after randomization

    Subject analysis set title
    Full Analysis Set (CZP 200 mg treated subjects)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: - Subjects with Good Clinical Practice (GCP) violations - Subjects who were not diagnosed (definitely) with Crohn’s Disease - Subjects who received no dose of study medication - Subjects with no data after randomization

    Subject analysis set title
    Full Analysis Set (CZP 400 mg treated subjects)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set was defined as the subjects who were randomized and allocated to study medication, but excluded the following subjects as determined by data review prior to unblinding: - Subjects with Good Clinical Practice (GCP) violations - Subjects who were not diagnosed (definitely) with Crohn’s Disease - Subjects who received no dose of study medication - Subjects with no data after randomization

    Primary: Crohn’s Disease Activity Index (CDAI) response (clinical response or remission) at Week 6

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    End point title
    		 Crohn’s Disease Activity Index (CDAI) response (clinical response or remission) at Week 6 [1]
    End point description
    CDAI Response is presented as the percentage of subjects with clinical response at Week 6 or remission at Week 6. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) – (CDAI score at Week 0). Remission is defined as a CDAI of <= 150 at Week 6.
    End point type
    Primary
    End point timeframe
    Baseline, Week 6
    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: No formal statistical hypothesis testing was planned for this study. Results were summarized in tables as descriptive statistics only.
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    25 (10 to 40)
    43.3 (25.6 to 61.1)
    48.4 (30.8 to 66)
    No statistical analyses for this end point

    Secondary: Crohn’s Disease Activity Index (CDAI) score at Week 2

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    End point title
    		 Crohn’s Disease Activity Index (CDAI) score at Week 2
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    29
    29
    31
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    255.9 ( 68.02 )
    214.2 ( 83.51 )
    224.9 ( 85.05 )
    No statistical analyses for this end point

    Secondary: Crohn’s Disease Activity Index (CDAI) score at Week 4

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    End point title
    		 Crohn’s Disease Activity Index (CDAI) score at Week 4
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    243.1 ( 68.57 )
    199.7 ( 91.25 )
    204.6 ( 75.1 )
    No statistical analyses for this end point

    Secondary: Crohn’s Disease Activity Index (CDAI) score at Week 6

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    End point title
    		 Crohn’s Disease Activity Index (CDAI) score at Week 6
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. The CDAI score can range from 0-600 (600 indicating the worst disease). It is the sum of 8 subscores, only the summary score is used here. A CDAI score of 150 or less is considered as remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    232.4 ( 89.28 )
    211 ( 99.91 )
    198.1 ( 87.88 )
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve CDAI response at Week 2

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    End point title
    		 Percentage of subjects who achieve CDAI response at Week 2
    End point description
    CDAI Response at Week 2 is defined as clinical response at Week 2 or remission at Week 2. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) – (CDAI score at Week 0). Remission is defined as a CDAI score of ≤ 150 points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    15.6 (3 to 28.2)
    40 (22.5 to 57.5)
    32.3 (15.8 to 48.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve CDAI response at Week 4

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    End point title
    		 Percentage of subjects who achieve CDAI response at Week 4
    End point description
    CDAI Response at Week 4 is defined as clinical response at Week 4 or remission at Week 4. Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) – (CDAI score at Week 0). Remission is defined as a CDAI score of ≤ 150 points.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    21.9 (7.6 to 36.2)
    46.7 (28.8 to 64.5)
    38.7 (21.6 to 55.9)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 2

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    End point title
    		 Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 2
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    28.1 (12.5 to 43.7)
    46.7 (28.8 to 64.5)
    45.2 (27.6 to 62.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 4

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    End point title
    		 Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 4
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    25 (10 to 40)
    56.7 (38.9 to 74.4)
    54.8 (37.3 to 72.4)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 6

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    End point title
    		 Percentage of subjects who achieve a reduction in CDAI scores of at least 70 points at Week 6
    End point description
    The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    43.8 (26.6 to 60.9)
    53.3 (35.5 to 71.2)
    61.3 (44.1 to 78.4)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve remission (CDAI <= 150) at Week 2

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    End point title
    		 Percentage of subjects who achieve remission (CDAI <= 150) at Week 2
    End point description
    Remission at Week 2 is defined as a CDAI score <= 150 points at Week 2.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    3.1 (0 to 9.2)
    20 (5.7 to 34.3)
    16.1 (3.2 to 29.1)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve remission (CDAI <= 150) at Week 4

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    End point title
    		 Percentage of subjects who achieve remission (CDAI <= 150) at Week 4
    End point description
    Remission at Week 4 is defined as a CDAI score <= 150 points at Week 4.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    6.3 (0 to 14.6)
    26.7 (10.8 to 42.5)
    22.6 (7.9 to 37.3)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve remission (CDAI <= 150) at Week 6

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    End point title
    		 Percentage of subjects who achieve remission (CDAI <= 150) at Week 6
    End point description
    Remission at Week 6 is defined as a CDAI score <= 150 points at Week 6.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    15.6 (3 to 28.2)
    26.7 (10.8 to 42.5)
    32.3 (15.8 to 48.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 2

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    End point title
    		 Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 2
    End point description
    Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 2) – (CDAI score at Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    15.6 (3 to 28.2)
    36.7 (19.4 to 53.9)
    29 (13.1 to 45)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 4

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    End point title
    		 Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 4
    End point description
    Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 4) – (CDAI score at Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    18.8 (5.2 to 32.3)
    36.7 (19.4 to 53.9)
    32.3 (15.8 to 48.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 6

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    End point title
    		 Percentage of subjects who achieve clinical response (reduction in CDAI scores of at least 100 points) at Week 6
    End point description
    Clinical response is defined as at least a 100-point decrease from the Week 0 CDAI score, where change = (CDAI score at Week 6) – (CDAI score at Week 0).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: percentage of subjects
    number (confidence interval 95%)
        Percentage of Subjects (95 % CI)
    21.9 (7.6 to 36.2)
    36.7 (19.4 to 53.9)
    41.9 (24.6 to 59.3)
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 2

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 2
    End point description
    The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    29
    29
    31
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    171.3 ( 22.45 )
    166.1 ( 22.14 )
    169.7 ( 23.24 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 4

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 4
    End point description
    The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    172.6 ( 24.04 )
    169.4 ( 21.75 )
    170.3 ( 23.72 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 6

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) global score at Week 6
    End point description
    The IBDQ global score is calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: units on a scale
    arithmetic mean (standard deviation)
        arithmetic mean (standard deviation)
    173.1 ( 25.49 )
    165.6 ( 23.25 )
    170.8 ( 24.54 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 2

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 2
    End point description
    The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: - Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) - Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) - Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) - Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: units on a scale
    arithmetic mean (standard deviation)
        Bowel Symptoms Domain Score (n=29, 29, 31)
    54.4 ( 7.17 )
    53.4 ( 8.18 )
    54.7 ( 8.77 )
        Systemic Symptoms Domain Score (n=29, 29, 31)
    22.4 ( 5.01 )
    22.4 ( 5.17 )
    22.7 ( 4.51 )
        Emotional Function Domain Score (n=29, 29, 31)
    65.3 ( 8.91 )
    62.3 ( 9.54 )
    63.3 ( 8.53 )
        Social Function Domain Score (n=28, 29, 31)
    29.4 ( 5.64 )
    28 ( 4.33 )
    29 ( 5.03 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 4

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 4
    End point description
    The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: - Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) - Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) - Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) - Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: units on a scale
    arithmetic mean (standard deviation)
        Bowel Symptoms Domain Score (n=28, 27, 30)
    55.4 ( 7.22 )
    54 ( 9 )
    55.5 ( 8.04 )
        Systemic Symptoms Domain Score (n=28, 27, 30)
    23.3 ( 5.49 )
    23.4 ( 4.21 )
    22.9 ( 4.44 )
        Emotional Function Domain Score (n=28, 27, 30)
    65.3 ( 8.85 )
    63.1 ( 8.9 )
    63.2 ( 9.55 )
        Social Function Domain Score (n=27, 27, 30)
    28.8 ( 6.73 )
    28.9 ( 4.82 )
    28.7 ( 5.62 )
    No statistical analyses for this end point

    Secondary: Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 6

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    End point title
    		 Inflammatory Bowel Disease Questionnaire (IBDQ) domain scores at Week 6
    End point description
    The total IBDQ score consists of 32 questions, each ranging from 1 to 7, with higher scores indicating a better quality of life. There are 4 IBDQ Domain Scores: - Bowel Symptoms Domain Score, ranging from 10 to 70 (10 questions ranging from 1 to 7) - Systemic Symptoms Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 ) - Emotional Function Domain Score, ranging from 12 to 84 (12 questions ranging from 1 to 7) - Social Function Domain Score, ranging from 5 to 35 (5 questions ranging from 1 to 7 )
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    32
    30
    31
    Units: units on a scale
    arithmetic mean (standard deviation)
        Bowel Symptoms Domain Score (n=28, 27, 30 )
    55.4 ( 7.77 )
    51.8 ( 8.44 )
    55.8 ( 8.43 )
        Systemic Symptoms Domain Score (n= 28, 27, 30)
    23.3 ( 6.74 )
    22.4 ( 4.49 )
    23.4 ( 4.62 )
        Emotional Function Domain Score (n= 28, 27, 30)
    65.3 ( 8.76 )
    63.2 ( 9.45 )
    62.1 ( 10.43 )
        Social Function Domain Score (n= 27, 27, 30)
    29.2 ( 6.48 )
    28.1 ( 5.69 )
    29.5 ( 5.09 )
    No statistical analyses for this end point

    Secondary: Concentration of C-reactive Protein (CRP) Value at Week 2

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    End point title
    		 Concentration of C-reactive Protein (CRP) Value at Week 2
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    29
    29
    31
    Units: mg/L
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    22.15 (15.43 to 31.8)
    13.58 (9.45 to 19.52)
    13.86 (9.11 to 21.09)
    No statistical analyses for this end point

    Secondary: Concentration of C-reactive Protein (CRP) Value at Week 4

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    End point title
    		 Concentration of C-reactive Protein (CRP) Value at Week 4
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: mg/L
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    23.47 (16.02 to 34.4)
    12.87 (8.56 to 19.36)
    12.02 (8.68 to 16.65)
    No statistical analyses for this end point

    Secondary: Concentration of C-reactive Protein (CRP) Value at Week 6

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    End point title
    		 Concentration of C-reactive Protein (CRP) Value at Week 6
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: mg/L
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    23.32 (16.95 to 32.07)
    15.1 (9.46 to 24.11)
    12.62 (8.79 to 18.11)
    No statistical analyses for this end point

    Secondary: C-reactive protein (CRP) Ratio to Baseline at Week 2

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    End point title
    		 C-reactive protein (CRP) Ratio to Baseline at Week 2
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    29
    29
    31
    Units: ratio
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    0.85 (0.64 to 1.13)
    0.58 (0.42 to 0.8)
    0.5 (0.35 to 0.72)
    No statistical analyses for this end point

    Secondary: C-reactive protein (CRP) Ratio to Baseline at Week 4

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    End point title
    		 C-reactive protein (CRP) Ratio to Baseline at Week 4
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: ratio
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    1.04 (0.83 to 1.31)
    0.53 (0.37 to 0.76)
    0.44 (0.32 to 0.6)
    No statistical analyses for this end point

    Secondary: C-reactive protein (CRP) Ratio to Baseline at Week 6

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    End point title
    		 C-reactive protein (CRP) Ratio to Baseline at Week 6
    End point description
    CRP data for subjects receiving rescue medication were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6
    End point values
    		 Full Analysis Set (Placebo treated subjects) Full Analysis Set (CZP 200 mg treated subjects) Full Analysis Set (CZP 400 mg treated subjects)
    Number of subjects analysed
    28
    27
    30
    Units: ratio
    geometric mean (confidence interval 95%)
        Geometric Mean (95% CI)
    1.03 (0.85 to 1.25)
    0.63 (0.4 to 0.98)
    0.46 (0.32 to 0.66)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 400 mg
    Reporting group description
    		 Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4.

    Reporting group title
    Certolizumab pegol 200 mg
    Reporting group description
    		 Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4.

    Serious adverse events
    		 Placebo Certolizumab pegol 400 mg Certolizumab pegol 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 32 (9.38%)
    3 / 32 (9.38%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Certolizumab pegol 400 mg Certolizumab pegol 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 32 (50.00%)
    14 / 32 (43.75%)
    11 / 30 (36.67%)
    Investigations
    White blood cell count decreased
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    2
    1
    3
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    3
    Vomiting
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    3
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    2
    Pharynx discomfort
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 30 (0.00%)
         occurrences all number
    1
    2
    0
    Skin and subcutaneous tissue disorders
    Comedone
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    10 / 32 (31.25%)
    7 / 32 (21.88%)
    7 / 30 (23.33%)
         occurrences all number
    11
    9
    8

    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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    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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