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    Clinical Trial Results:
    A 26-week, multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn's disease patients, who showed clinical efficacy in a remission induction study (Study C87037), at Week 26 after subcutaneous administration of CDP870 400 mg from Week 8 until Week 24 at 4-week intervals

    Summary
    EudraCT number
    2014-004354-34
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    08 Apr 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    17 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C87047
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00329550
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Japan Co., Ltd.
    Sponsor organisation address
    8-17-1 Nishi-Shinjuku, 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 Jun 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of certolizumab pegol 400 mg administered subcutaneously (sc) at 4-week intervals from Week 8 to Week 24 in active Crohn's Disease (CD) subjects showing clinical efficacy at Week 6 of the induction study (Study C87037 [2014-004399-42]).
    Protection of trial subjects
    Not applicable
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    10 May 2006
    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
    Japan: 40
    Worldwide total number of subjects
    40
    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)
    5
    Adults (18-64 years)
    35
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment into this extension study was between March 2006 and April 2008. Of the 26 hospitals and medical centers throughout Japan in the main study, 16 sites went on to enter subjects in this extension study.

    Pre-assignment
    Screening details
    To enter this single-group extension study, C87047 (NCT00329550), subjects had to have responded at Week 6 of the double-blind main study, C87037 (NCT00291668). Recruitment details are provided for the 40 subjects who entered this extension study by the three possible treatment sequences received across both studies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CZP 400 mg / Placebo
    Arm description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CDP870
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study.

    Arm title
    CZP 400 mg / CZP 200 mg
    Arm description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CDP870
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study.

    Arm title
    CZP 400 mg / CZP 400 mg
    Arm description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab Pegol
    Investigational medicinal product code
    CDP870
    Other name
    Cimzia
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study.

    Number of subjects in period 1
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Started
    9
    15
    16
    Completed
    5
    11
    12
    Not completed
    4
    4
    4
         Due to Relocation
    -
    -
    1
         SAE, non-fatal
    2
    3
    2
         Consent withdrawn by subject
    1
    -
    1
         AE, non-serious non-fatal
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CZP 400 mg / Placebo
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total
    Number of subjects
    9 15 16 40
    Age Categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    1 2 2 5
        Adults (18-64 years)
    8 13 14 35
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    32.7 ± 10.4 29.3 ± 9.1 33.3 ± 10 -
    Gender Categorical
    Units: Subjects
        Female
    2 3 4 9
        Male
    7 12 12 31
    Region of Enrollment
    Units: Subjects
        Japan
    9 15 16 40

    End points

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    End points reporting groups
    Reporting group title
    CZP 400 mg / Placebo
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Primary: Percentage of Crohn’s Disease Activity Index (CDAI) responders at Week 26

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    End point title
    Percentage of Crohn’s Disease Activity Index (CDAI) responders at Week 26 [1]
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Primary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    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
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    44.4
    73.3
    60
        Percentage of CDAI non-responders
    55.6
    26.7
    40
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 8

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 8
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -126.7 ± 100.9
    -124.9 ± 76.7
    -141.8 ± 62.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 12

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 12
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -152.6 ± 96.8
    -145.4 ± 80.5
    -152.8 ± 54.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 16

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 16
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -162.8 ± 98.9
    -142.2 ± 84.3
    -143.3 ± 69.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -147 ± 38.8
    -149.4 ± 85.6
    -130.7 ± 70.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 24

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 24
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -158.6 ± 53.7
    -153.3 ± 53.7
    -138.9 ± 80
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 26

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Week 26
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -131.1 ± 32.8
    -173.8 ± 46.5
    -153.1 ± 70.8
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Last Visit [Week 26 for completers or the Withdrawal Visit for premature withdrawals]

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    End point title
    Change from Week 0 in Crohn’s Disease Activity Index (CDAI) Score at Last Visit [Week 26 for completers or the Withdrawal Visit for premature withdrawals]
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -132.7 ± 62.6
    -143.2 ± 88.5
    -152.5 ± 67.9
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 8

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 8
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    55.6
    66.7
    80
        Percentage of CDAI non-responders
    44.4
    33.3
    20
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 12

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 12
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    77.8
    73.3
    86.7
        Percentage of CDAI non-responders
    22.2
    26.7
    13.3
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 16

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 16
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    77.8
    60
    66.7
        Percentage of CDAI non-responders
    22.2
    40
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 20

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 20
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    66.7
    60
    60
        Percentage of CDAI non-responders
    33.3
    40
    40
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 24

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 24
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    44.4
    60
    53.3
        Percentage of CDAI non-responders
    55.6
    40
    46.7
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Last Visit [Week 26 for completers or the Withdrawal Visit for premature withdrawals]

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Last Visit [Week 26 for completers or the Withdrawal Visit for premature withdrawals]
    End point description
    CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    44.4
    73.3
    60
        Percentage of CDAI non-responders
    55.6
    26.7
    40
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 8

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    End point title
    Percentage of subjects achieving remission at Week 8
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    40
    53.3
        Percentage of subjects not in remission
    66.7
    60
    46.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 12

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    End point title
    Percentage of subjects achieving remission at Week 12
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    44.4
    46.7
    53.3
        Percentage of subjects not in remission
    55.6
    53.3
    46.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 16

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    End point title
    Percentage of subjects achieving remission at Week 16
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    44.4
    46.7
    40
        Percentage of subjects not in remission
    55.6
    53.3
    60
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 20

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    End point title
    Percentage of subjects achieving remission at Week 20
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    22.2
    53.3
    40
        Percentage of subjects not in remission
    77.8
    46.7
    60
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 24

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    End point title
    Percentage of subjects achieving remission at Week 24
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    22.2
    46.7
    40
        Percentage of subjects not in remission
    77.8
    53.3
    60
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 26

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    End point title
    Percentage of subjects achieving remission at Week 26
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    22.2
    46.7
    46.7
        Percentage of subjects not in remission
    77.8
    53.3
    53.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals)

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    End point title
    Percentage of subjects achieving remission at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    The Crohn’s Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn’s disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    22.2
    46.7
    46.7
        Percentage of subjects not in remission
    77.8
    53.3
    53.3
    No statistical analyses for this end point

    Secondary: Time to disease progression

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    End point title
    Time to disease progression
    End point description
    Time to disease progression is defined as the earliest of: - time to an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits, - time to use of rescue therapy, or, - time to subject withdrawal from the study.
    End point type
    Secondary
    End point timeframe
    Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    Notes
    [2] - Less than 50 % of subjects had their disease progress by Week 26. This analysis was not performed.
    [3] - Less than 50 % of subjects had their disease progress by Week 26. This analysis was not performed.
    [4] - Less than 50 % of subjects had their disease progress by Week 26. This analysis was not performed.
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    33.8 ± 25.6
    30.4 ± 25.8
    23.7 ± 20.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    37.6 ± 27
    29.9 ± 28.6
    25.5 ± 20.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    31 ± 31.6
    30.1 ± 25.4
    22.6 ± 22.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    32.2 ± 20.7
    31.6 ± 27.6
    19.2 ± 25.9
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    34 ± 13.4
    32.7 ± 24.6
    23.6 ± 22.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    33.4 ± 17
    38.4 ± 27
    28.2 ± 19.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score

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    End point title
    Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    28 ± 21.5
    33.3 ± 27.7
    26.1 ± 20.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    10.7 ± 5.8
    10.3 ± 8.6
    9.5 ± 10.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    12.6 ± 6.9
    10.2 ± 10.8
    9.8 ± 8.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.9 ± 8.3
    8.8 ± 9.6
    6.7 ± 7.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.5 ± 8.3
    11.3 ± 9.7
    6.7 ± 8.8
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    11 ± 3
    10.4 ± 8.7
    8 ± 9.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    11.6 ± 4.2
    12 ± 10.4
    8.8 ± 9.9
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score

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    End point title
    Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.6 ± 5.8
    10.7 ± 10.1
    8.1 ± 9.8
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    7.6 ± 7
    7.1 ± 5.9
    5.7 ± 4.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    7.4 ± 7.8
    7.4 ± 6
    5.9 ± 5.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.8 ± 9.1
    7.9 ± 5.9
    5.9 ± 6.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    7.5 ± 3.4
    7.3 ± 6.6
    4.9 ± 6.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    8.2 ± 3.1
    7.5 ± 6.7
    6.2 ± 3.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.4 ± 3.5
    8.7 ± 5.6
    7.2 ± 3.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score

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    End point title
    Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.1 ± 6.8
    8.8 ± 5.1
    7.2 ± 3.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

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    End point title
    Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.4 ± 7
    7.5 ± 8.6
    5.1 ± 8.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

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    End point title
    Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    10.8 ± 7.6
    7.7 ± 8.2
    5.4 ± 9.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

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    End point title
    Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    8 ± 8.2
    7.8 ± 8.4
    6.1 ± 9.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

    Close Top of page
    End point title
    Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    8.5 ± 9.4
    6.8 ± 9.4
    4.1 ± 10.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

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    End point title
    Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    8.3 ± 6.1
    8.6 ± 9.1
    6.2 ± 10.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

    Close Top of page
    End point title
    Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    9.4 ± 7.2
    11.3 ± 11.1
    6.8 ± 8.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score

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    End point title
    Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    7.4 ± 6.8
    9 ± 11.6
    5.8 ± 9
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.1 ± 7.4
    5.5 ± 7.1
    3.5 ± 4
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.9 ± 7.9
    4.5 ± 8.9
    4.5 ± 4.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.4 ± 7.7
    5.6 ± 7.3
    4 ± 4.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.7 ± 5.8
    6.1 ± 7.9
    3.6 ± 5.9
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.5 ± 6.1
    6.2 ± 7.8
    3.3 ± 4.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6 ± 5.8
    6.4 ± 7.8
    5.7 ± 5.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score

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    End point title
    Change from Week 0 to Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score
    End point description
    The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.9 ± 6
    4.8 ± 8.5
    5.2 ± 5.2
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 0

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    End point title
    C-Reactive Protein (CRP) Level at Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: mg/L
    geometric mean (full range (min-max))
        mean (standard deviation)
    21.37 (1 to 68)
    26.31 (11 to 77)
    25.88 (5 to 92)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 8

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    End point title
    C-Reactive Protein (CRP) Level at Week 8
    End point description
    End point type
    Secondary
    End point timeframe
    Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: mg/L
    geometric mean (full range (min-max))
        mean (standard deviation)
    23.8 (6 to 67)
    19.11 (1 to 115)
    11.61 (5 to 67)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 12

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    End point title
    C-Reactive Protein (CRP) Level at Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    12.55 (1 to 38)
    14.91 (1 to 100)
    11.64 (4 to 56)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 16

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    End point title
    C-Reactive Protein (CRP) Level at Week 16
    End point description
    End point type
    Secondary
    End point timeframe
    Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    16.12 (1 to 58)
    16.06 (1 to 99)
    14.05 (5 to 76)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 20

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    End point title
    C-Reactive Protein (CRP) Level at Week 20
    End point description
    End point type
    Secondary
    End point timeframe
    Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    17.16 (0 to 47)
    13.16 (3 to 73)
    17.44 (4 to 63)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 24

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    End point title
    C-Reactive Protein (CRP) Level at Week 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    10.97 (1 to 40)
    12.44 (1 to 77)
    16.84 (5 to 87)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 26

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    End point title
    C-Reactive Protein (CRP) Level at Week 26
    End point description
    End point type
    Secondary
    End point timeframe
    Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    15.94 (0 to 48)
    9.96 (2 to 43)
    13.11 (4 to 78)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals)

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    End point title
    C-Reactive Protein (CRP) Level at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    End point type
    Secondary
    End point timeframe
    Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: mg/L
    geometric mean (full range (min-max))
        Geometric mean (full range)
    19.81 (0 to 48)
    13.12 (2 to 81)
    14.04 (4 to 78)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    1.11 (0.5 to 6)
    0.73 (0.1 to 5.6)
    0.45 (0.1 to 1.4)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    14
    15
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.63 (0.2 to 1.4)
    0.55 (0.1 to 1.7)
    0.45 (0.1 to 1.4)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    8
    13
    14
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.81 (0.2 to 1.9)
    0.59 (0.1 to 1.9)
    0.53 (0.3 to 2.4)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    12
    14
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.65 (0 to 1.4)
    0.53 (0.1 to 1.9)
    0.66 (0.1 to 2)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    6
    11
    13
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.72 (0.2 to 1.8)
    0.5 (0.1 to 1.7)
    0.62 (0.1 to 1.8)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    5
    11
    12
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.63 (0 to 1.2)
    0.4 (0.1 to 1.7)
    0.47 (0.1 to 2.5)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) to Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) to Week 0
    End point description
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    7
    13
    13
    Units: ratio
    geometric mean (full range (min-max))
        Geometric mean (full range)
    0.72 (0 to 1.2)
    0.48 (0.1 to 1.8)
    0.52 (0.1 to 2.5)
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 8 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 8 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    77.8
    73.3
    86.7
        Percentage of 70-point non-responders
    22.2
    26.7
    13.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 12 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 12 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    77.8
    80
    93.3
        Percentage of 70-point non-responders
    22.2
    20
    6.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 16 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 16 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    77.8
    66.7
    66.7
        Percentage of 70-point non-responders
    22.2
    33.3
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 20 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 20 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    66.7
    60
    73.3
        Percentage of 70-point non-responders
    33.3
    40
    26.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 24 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 24 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    55.6
    66.7
    60
        Percentage of 70-point non-responders
    44.4
    33.3
    40
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Week 26 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Week 26 achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    55.6
    73.3
    73.3
        Percentage of 70-point non-responders
    44.4
    26.7
    26.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0

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    End point title
    Percentage of subjects at Last Visit (Week 26 for completers or the Withdrawal Visit for premature withdrawals) achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0
    End point description
    CDAI is used to quantify the symptoms of subjects with Crohn’s disease. A score of 150 or below indicates 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 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: Percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    55.6
    73.3
    73.3
        Percentage of 70-point non-responders
    44.4
    26.7
    26.7
    No statistical analyses for this end point

    Post-hoc: Number of subjects with disease progression

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    End point title
    Number of subjects with disease progression
    End point description
    Disease progression is defined as: - an increase from Week 6 of ≥100 points in Crohn’s Disease Activity Index (CDAI) score and CDAI >175 points for at least 2 consecutive visits, - use of rescue therapy, or, - subject withdrawal from the study.
    End point type
    Post-hoc
    End point timeframe
    Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.
    End point values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Number of subjects analysed
    9
    15
    15
    Units: subjects
        Number of subjects
    2
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from the day after the end of the double-blind main study up to and including 12 weeks following the last dose received in this extension study for each subject (i.e., up to 30 weeks).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set, including all enrolled subjects who received study medication at least once.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    CZP 400 mg / Placebo
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)

    Serious adverse events
    CZP 400 mg / Placebo CZP 400 mg / CZP 400 mg CZP 400 mg / CZP 200 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 16 (31.25%)
    5 / 15 (33.33%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (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
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 16 (18.75%)
    4 / 15 (26.67%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (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
    Pancreatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    CZP 400 mg / Placebo CZP 400 mg / CZP 400 mg CZP 400 mg / CZP 200 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 9 (88.89%)
    15 / 16 (93.75%)
    12 / 15 (80.00%)
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Feeling abnormal
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    1
    1
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Neurosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Fall
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural hypotension
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Antinuclear antibody increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Antinuclear antibody positive
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    DNA antibody positive
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    2
    2
    1
    White blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngolaryngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pharynx discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    0
    2
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Tension headache
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Crohn's disease
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Glossitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    0
    2
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic function abnormal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Liver disorder
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia areata
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis psoriasiform
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Eczema nummular
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Myalgia intercostal
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Candidiasis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Colitis pseudomembranous
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Dental caries
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Infection
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 16 (12.50%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Laryngopharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 9 (22.22%)
    10 / 16 (62.50%)
    3 / 15 (20.00%)
         occurrences all number
    4
    12
    4
    Otitis externa
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 16 (6.25%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 16 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2

    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.
    Due to the small number of subjects in this study, the percentages of subjects with adverse events may be misleading.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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