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    Clinical Trial Results:
    A multi-center, open-label study to investigate the efficacy and safety of CDP870 in active Crohn’s disease patients, who showed no clinical efficacy in a remission induction study (Study CDP870-037) but showed clinical efficacy after additional remission induction therapy was applied, at Week 26 after subcutaneous administration of CDP870 400mg from Week 8 until Week 24 at 4-week intervals

    Summary
    EudraCT number
    2014-004400-30
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    11 May 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C87048
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00329420
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Japan Co., Ltd.
    Sponsor organisation address
    2-2 Kanda Surugadai, Tokyo, Japan, 101-0062
    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
    27 Aug 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 May 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 400mg in subjects with active CD who were non-responders in the induction study (Study CDP870-037), but who responded to a second induction with certolizumab pegol. Subjects underwent re-induction with certolizumab pegol 400mg administered every 2 weeks for 3 doses; subjects who responded to the second induction received certolizumab pegol 400mg administered every 4 weeks for 5 doses.
    Protection of trial subjects
    Not applicable
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    02 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: 46
    Worldwide total number of subjects
    46
    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)
    1
    Adults (18-64 years)
    45
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Non-responders at Week 6 of the double-blind main study, C87037 (2014-004399-42) could enter this single-group open-label extension study, C87048 (2014-004400-30). Recruitment into this extension study was between May 2006 and May 2008. Of the 26 hospitals in the main study C87037 16 sites went on to enter subjects into this extension study.

    Pre-assignment
    Screening details
    Subjects who responded to re-induction (Week 14 visit) in this extension study could enter the 4-weekly dosing phase. Efficacy data are based on these 26 subjects. However, adverse event data are based on all 46 subjects who entered this extension study. Data are presented by the three possible treatment sequences received across both studies.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    CZP 400 mg / Placebo
    Arm description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42)
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42)

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    Certolizumab pegol CZP
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42) Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 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 (2014-004399-42) Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Arm title
    CZP 400 mg / CZP 200 mg
    Arm description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    Certolizumab pegol CZP
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42) Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 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 (2014-004399-42) Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Arm title
    CZP 400 mg / CZP 400 mg
    Arm description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    Certolizumab pegol CZP
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42) Certolizumab pegol (CZP)400 mg (3 doses 2-weekly then 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 (2014-004399-42) Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Number of subjects in period 1
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg
    Started
    18
    13
    15
    Moved to maintenance period
    12
    7
    7
    Completed
    8
    5
    6
    Not completed
    10
    8
    9
         Withdrawal of Consent
    1
    -
    1
         Lack of efficacy
    3
    2
    1
         SAE, non-fatal
    1
    1
    2
         Did not respond to re-induction
    3
    5
    4
         AE, non-serious non-fatal
    2
    -
    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 (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Reporting group values
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total
    Number of subjects
    18 13 15 46
    Age Categorical
    Units: Subjects
        <=18 years
    1 0 0 1
        Between 18 and 65 years
    17 13 15 45
        >=65 years
    0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    30.4 ± 7.5 37.5 ± 8.2 29.9 ± 5.9 -
    Gender Categorical
    Units: Subjects
        Female
    4 4 3 11
        Male
    14 9 12 35
    Region of Enrollment
    Units: Subjects
        Japan
    18 13 15 46

    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 (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Primary: Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 34

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    End point title
    Percentage of Crohn’s Disease Activity Index (CDAI) Responders at Week 34 [1]
    End point description
    Crohn's disease activity index (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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    66.7
    28.6
    42.9
        Percentage of CDAI non-responders
    33.3
    71.4
    57.1
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -20.5 ± 81.6
    -53.1 ± 38.1
    -63.8 ± 26.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 10
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -96.1 ± 76.1
    -100.3 ± 35.4
    -90 ± 18.2
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -101.3 ± 56.6
    -100.5 ± 49.3
    -109.9 ± 36.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 14
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -124.3 ± 50.4
    -131.7 ± 41.3
    -147 ± 45.2
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -121 ± 57.7
    -70.4 ± 84.1
    -136.2 ± 32.2
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -105.3 ± 82.9
    -79.6 ± 60.9
    -130.9 ± 62.5
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -89.8 ± 79.8
    -70.6 ± 91.3
    -150.2 ± 48
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 28
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -118.2 ± 62.6
    -67.3 ± 77.1
    -154.8 ± 74.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 32
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -89 ± 88.3
    -77.3 ± 70.9
    -128.3 ± 75.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34

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    End point title
    Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 34
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -134.9 ± 39.3
    -97.4 ± 33.1
    -132.7 ± 89.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit (Week 34 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 34 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -112 ± 75.6
    -61 ± 93.7
    -132.7 ± 89.7
    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
    Crohn's disease activity index (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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    8.3
    14.3
    14.3
        Percentage of CDAI non-responders
    91.7
    85.7
    85.7
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 10

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 10
    End point description
    Crohn's disease activity index (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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    41.7
    71.4
    42.9
        Percentage of CDAI non-responders
    58.3
    28.6
    57.1
    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
    Crohn's disease activity index (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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    50
    71.4
    57.1
        Percentage of CDAI non-responders
    50
    28.6
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 14

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 14
    End point description
    Crohn's disease activity index (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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    100
    100
    100
        Percentage of CDAI non-responders
    0
    0
    0
    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
    Crohn's disease activity index (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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    66.7
    42.9
    85.7
        Percentage of CDAI non-responders
    33.3
    57.1
    14.3
    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
    Crohn's disease activity index (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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    41.7
    28.6
    85.7
        Percentage of CDAI non-responders
    58.3
    71.4
    14.3
    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
    Crohn's disease activity index (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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    41.7
    57.1
    71.4
        Percentage of CDAI non-responders
    58.3
    42.9
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 28

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 28
    End point description
    Crohn's disease activity index (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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    50
    28.6
    57.1
        Percentage of CDAI non-responders
    50
    71.4
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 32

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    End point title
    Percentage of Crohn's Disease Activity Index (CDAI) responders at Week 32
    End point description
    Crohn's disease activity index (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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    33.3
    28.6
    57.1
        Percentage of CDAI non-responders
    66.7
    71.4
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of Crohn's Disease Activity Index (CDAI) responders at Last Visit (Week 34 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 34 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    Crohn's disease activity index (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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of CDAI responders
    66.7
    28.6
    42.9
        Percentage of CDAI non-responders
    33.3
    71.4
    57.1
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    0
    0
    14.3
        Percentage of subjects not in remission
    100
    100
    85.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 10

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    End point title
    Percentage of subjects achieving remission at Week 10
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    42.9
    14.3
        Percentage of subjects not in remission
    66.7
    57.1
    85.7
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    25
    42.9
    42.9
        Percentage of subjects not in remission
    75
    57.1
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 14

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    End point title
    Percentage of subjects achieving remission at Week 14
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    66.7
    71.4
    71.4
        Percentage of subjects not in remission
    33.3
    28.6
    28.6
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    28.6
    57.1
        Percentage of subjects not in remission
    66.7
    71.4
    42.9
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    28.6
    57.1
        Percentage of subjects not in remission
    66.7
    71.4
    42.9
    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
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    16.7
    42.9
    71.4
        Percentage of subjects not in remission
    83.3
    57.1
    28.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 28

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    End point title
    Percentage of subjects achieving remission at Week 28
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    25
    28.6
    57.1
        Percentage of subjects not in remission
    75
    71.4
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 32

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    End point title
    Percentage of subjects achieving remission at Week 32
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    16.7
    28.6
    42.9
        Percentage of subjects not in remission
    83.3
    71.4
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Week 34

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    End point title
    Percentage of subjects achieving remission at Week 34
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    28.6
    42.9
        Percentage of subjects not in remission
    66.7
    71.4
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving remission at Last Visit (Week 34 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 34 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    Crohn's disease activity index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
    End point type
    Secondary
    End point timeframe
    Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    12
    7
    7
    Units: Percentage of subjects
    number (not applicable)
        Percentage of subjects in remission
    33.3
    28.6
    42.9
        Percentage of subjects not in remission
    66.7
    71.4
    57.1
    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 14 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 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 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%)
        median (95% CI)
    ( to )
    ( to )
    ( to )
    Notes
    [2] - No data displayed because Outcome Measure has zero total participants analyzed.
    [3] - No data displayed because Outcome Measure has zero total participants analyzed.
    [4] - No data displayed because Outcome Measure has zero total participants analyzed.
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 8
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    4.6 ± 15.3
    9.1 ± 7.5
    5.3 ± 13.8
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 10
    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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    17 ± 17.5
    20.9 ± 24.9
    15.1 ± 13.4
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 12
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    17.3 ± 12
    26.3 ± 33.6
    20.1 ± 16.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 14
    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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    20.1 ± 12.3
    28.6 ± 22.9
    26.3 ± 16.1
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 16
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    16.3 ± 12.2
    15.3 ± 19.1
    20 ± 16.4
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 20
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    12.2 ± 16
    18.4 ± 27.5
    15.9 ± 14.7
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 24
    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
    9
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    8.3 ± 14.5
    7.6 ± 23.3
    18.4 ± 18
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 28
    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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    14.9 ± 20
    11.4 ± 24.3
    15.9 ± 19.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 32
    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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    11.3 ± 17.8
    11.2 ± 21.7
    25.3 ± 17
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Week 34
    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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    21.6 ± 16.9
    14.8 ± 23.6
    20.6 ± 17.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    15.6 ± 19.5
    10.8 ± 23.3
    20.6 ± 17.6
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 8
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.9 ± 7.5
    6.4 ± 5.6
    2.4 ± 5.3
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 10
    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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.2 ± 8.4
    10.6 ± 8.4
    5.9 ± 7.1
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 12
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.7 ± 4.4
    11.7 ± 9.7
    7.4 ± 7.9
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 14
    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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    6.9 ± 5.6
    12.3 ± 9.3
    9.3 ± 7
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 16
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.2 ± 6.3
    8.4 ± 9.9
    6.3 ± 7.2
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 20
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.5 ± 7.4
    9.9 ± 11.7
    5.1 ± 5.5
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 24
    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
    9
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    0.7 ± 5.3
    4.7 ± 11
    5.6 ± 8.2
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 28
    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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    4.6 ± 6
    8.3 ± 10
    5.4 ± 8.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 32
    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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.1 ± 6.7
    9.6 ± 11
    7.5 ± 5.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Week 34
    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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    7.1 ± 4.9
    11.8 ± 9.8
    5.8 ± 6.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.5 ± 6.9
    8.3 ± 12.2
    5.8 ± 6.5
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 8
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.4 ± 3.4
    0.6 ± 1.7
    1.7 ± 1.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 10
    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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    4.6 ± 4.4
    3.7 ± 6.2
    3.9 ± 1.3
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 12
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.7 ± 3.2
    5 ± 7.3
    5.1 ± 2.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 14
    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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.9 ± 3
    6.4 ± 4.3
    6.3 ± 3.1
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 16
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.5 ± 2.4
    3.9 ± 3.7
    5.3 ± 3.5
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 20
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.6 ± 4
    3.6 ± 6.3
    3.6 ± 2.6
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 24
    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
    9
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.1 ± 2.9
    2.1 ± 5.9
    4.1 ± 2.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 28
    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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3 ± 6.1
    3 ± 5.8
    4.4 ± 3.6
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 32
    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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.4 ± 4.3
    0.4 ± 3.1
    6.8 ± 3.8
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Week 34
    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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5 ± 3.2
    3 ± 4.8
    5.4 ± 2.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    4.2 ± 4.1
    3.2 ± 4.4
    5.4 ± 2.1
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 8
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    -0.3 ± 6.1
    2.1 ± 2.3
    0.4 ± 6.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 10
    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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.3 ± 4.7
    4.4 ± 9.7
    4.3 ± 5.9
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 12
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.5 ± 5.5
    7 ± 13.8
    5.3 ± 6.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 14
    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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.8 ± 4
    7.1 ± 10.3
    6.7 ± 8
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 16
    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
    12
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.5 ± 5.8
    3 ± 6.2
    6 ± 8.1
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 20
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.9 ± 6.5
    3.4 ± 10.7
    3.6 ± 6.9
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 24
    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
    9
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.1 ± 5.9
    1.6 ± 5.7
    6.1 ± 7.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 28
    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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    4.3 ± 5.8
    1.1 ± 8
    3.6 ± 7.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 32
    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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.9 ± 5.7
    1.8 ± 6.1
    7.7 ± 9.5
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Week 34
    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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    5.6 ± 6.7
    0 ± 8.6
    6.4 ± 10.9
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3.5 ± 7.1
    0.7 ± 7.9
    6.4 ± 10.9
    No statistical analyses for this end point

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

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    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 8
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.3 ± 3.6
    0 ± 2.4
    0.7 ± 3.7
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 10
    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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.5 ± 3
    2.1 ± 4.7
    1.1 ± 3.4
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 12
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3 ± 3.1
    2.6 ± 5.1
    2.3 ± 4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 14
    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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.8 ± 2.6
    2.7 ± 3.4
    4 ± 2
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 16
    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
    11
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.5 ± 2.1
    0 ± 3.9
    2.4 ± 2.1
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 20
    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
    10
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.8 ± 2.3
    1.6 ± 3
    3.6 ± 2.3
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 24
    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
    8
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.8 ± 2.7
    -0.9 ± 4.9
    2.6 ± 2.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 28
    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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    2.1 ± 2.7
    -1 ± 4.6
    2.4 ± 3.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 32
    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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.3 ± 3.4
    -0.6 ± 2.9
    3.3 ± 2.4
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Week 34
    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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    3 ± 3
    0 ± 3.4
    3 ± 3.1
    No statistical analyses for this end point

    Secondary: Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

    Close Top of page
    End point title
    Change from Week 0 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    10
    6
    5
    Units: score on a scale
    arithmetic mean (standard deviation)
        mean (standard deviation)
    1.7 ± 3.4
    -1.3 ± 4.5
    3 ± 3.1
    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 (N00291668)). '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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    19.58 (4 to 60)
    14.97 (10 to 25)
    26.45 (16 to 50)
    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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    22.06 (8 to 76)
    11.91 (4 to 41)
    16.7 (1 to 55)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 10

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    End point title
    C-Reactive Protein (CRP) Level at Week 10
    End point description
    End point type
    Secondary
    End point timeframe
    Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    7.76 (2 to 40)
    5.62 (3 to 13)
    12.01 (1 to 34)
    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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    7.82 (2 to 31)
    7.06 (3 to 14)
    13.39 (1 to 54)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 14

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    End point title
    C-Reactive Protein (CRP) Level at Week 14
    End point description
    End point type
    Secondary
    End point timeframe
    Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    9.57 (2 to 32)
    6.32 (4 to 14)
    15.3 (1 to 41)
    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
    12
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    12.54 (3 to 35)
    12.23 (3 to 45)
    15.1 (1 to 36)
    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
    11
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    12.27 (1 to 74)
    13.24 (4 to 50)
    14.99 (1 to 53)
    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
    9
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    9.11 (1 to 45)
    14.16 (4 to 33)
    15.7 (1 to 38)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 28

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    End point title
    C-Reactive Protein (CRP) Level at Week 28
    End point description
    End point type
    Secondary
    End point timeframe
    Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    8.79 (1 to 24)
    14.25 (4 to 40)
    26.81 (0 to 33)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 32

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    End point title
    C-Reactive Protein (CRP) Level at Week 32
    End point description
    End point type
    Secondary
    End point timeframe
    Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    15.28 (3 to 45)
    10.27 (2 to 24)
    16.71 (1 to 48)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Week 34

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    End point title
    C-Reactive Protein (CRP) Level at Week 34
    End point description
    End point type
    Secondary
    End point timeframe
    Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    9.19 (1 to 40)
    6.23 (2 to 16)
    23.52 (0 to 81)
    No statistical analyses for this end point

    Secondary: C-Reactive Protein (CRP) Level at Last Visit (Week 34 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 34 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    End point type
    Secondary
    End point timeframe
    Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: mg/L
    geometric mean (full range (min-max))
        geometric mean (full range)
    11.25 (1 to 75)
    8.46 (2 to 39)
    23.52 (0 to 81)
    No statistical analyses for this end point

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

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 8 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 8 divided by the CRP Level at Week 0
    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
    12
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    1.13 (0.4 to 4.3)
    0.8 (0.2 to 4.1)
    0.63 (0 to 3.4)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Week 10 to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 10 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 10 divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.4 (0.1 to 1.5)
    0.38 (0.1 to 1.2)
    0.45 (0 to 2)
    No statistical analyses for this end point

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

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 12 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 12 divided by the CRP Level at Week 0
    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
    12
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.4 (0.1 to 2)
    0.47 (0.2 to 1.1)
    0.51 (0 to 3.2)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Week 14 to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 14 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 14 divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.49 (0.1 to 5)
    0.42 (0.2 to 1)
    0.58 (0 to 2.4)
    No statistical analyses for this end point

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

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 16 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 16 divided by the CRP Level at Week 0
    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
    12
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.64 (0.1 to 5.3)
    0.82 (0.3 to 4.1)
    0.57 (0 to 2.3)
    No statistical analyses for this end point

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

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 20 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 20 divided by the CRP Level at Week 0
    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
    11
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.64 (0 to 5.5)
    0.88 (0.3 to 4.5)
    0.57 (0 to 3.1)
    No statistical analyses for this end point

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

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 24 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 24 divided by the CRP Level at Week 0
    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
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.48 (0 to 3.5)
    0.95 (0.4 to 2.4)
    0.59 (0 to 1.7)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Week 28 to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 28 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 28 divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    7
    7
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.46 (0 to 2.8)
    0.95 (0.2 to 2.7)
    1.06 (0 to 2.1)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Week 32 to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 32 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 32 divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    5
    6
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.9 (0.1 to 4.6)
    0.64 (0.2 to 1.2)
    0.62 (0 to 2.8)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Week 34 to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Week 34 to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Week 34 divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    5
    5
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.54 (0 to 2.8)
    0.39 (0.2 to 1.6)
    1.07 (0 to 3.5)
    No statistical analyses for this end point

    Secondary: Ratio of C-Reactive Protein (CRP) level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals) to CRP level at Week 0

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    End point title
    Ratio of C-Reactive Protein (CRP) level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals) to CRP level at Week 0
    End point description
    The ratio is calculated as the C-Reactive Protein (CRP) Level at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)divided by the CRP Level at Week 0
    End point type
    Secondary
    End point timeframe
    Week 0 and Last Visit (Week 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    11
    6
    5
    Units: ratio
    geometric mean (full range (min-max))
        geometric mean (full range)
    0.59 (0 to 2.8)
    0.54 (0.2 to 2.8)
    1.07 (0 to 3.5)
    No statistical analyses for this end point

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

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 8
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    33.3
    28.6
    42.9
        Percentage of 70-point non-responders
    66.7
    71.4
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 10

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 10
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 10 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 10' is 2 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    66.7
    85.7
    100
        Percentage of 70-point non-responders
    33.3
    14.3
    0
    No statistical analyses for this end point

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

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 12
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    75
    71.4
    85.7
        Percentage of 70-point non-responders
    25
    28.6
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 14

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 14
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 14 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is 6 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    100
    100
    100
        Percentage of 70-point non-responders
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 16
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    83.3
    57.1
    100
        Percentage of 70-point non-responders
    16.7
    42.9
    0
    No statistical analyses for this end point

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

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 20
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    75
    71.4
    85.7
        Percentage of 70-point non-responders
    25
    28.6
    14.3
    No statistical analyses for this end point

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

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 24
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    50
    71.4
    100
        Percentage of 70-point non-responders
    50
    28.6
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 28

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 28
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 28 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 28' is 20 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    58.3
    71.4
    85.7
        Percentage of 70-point non-responders
    41.7
    28.6
    14.3
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 32

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 32
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 32 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 32' is 24 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    41.7
    57.1
    57.1
        Percentage of 70-point non-responders
    58.3
    42.9
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 34

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Week 34
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 34' is 26 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    66.7
    42.9
    42.9
        Percentage of 70-point non-responders
    33.3
    57.1
    57.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)

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    End point title
    Percentage of subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0 at Last Visit (Week 34 for completers or the Withdrawal Visit for premature withdrawals)
    End point description
    70-point responders are subjects achieving a reduction in Crohn’s Disease Activity Index (CDAI) score of ≥70 points from Week 0. 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 34 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 34' is 26 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
    12
    7
    7
    Units: percentage of subjects
    number (not applicable)
        Percentage of 70-point responders
    66.7
    42.9
    42.9
        Percentage of 70-point non-responders
    33.3
    57.1
    57.1
    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 14 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 14 to Week 34 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 14' is the visit at which response to re-induction is assessed and 'Week 34' is 26 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
    12
    7
    7
    Units: subjects
        Number of subjects
    1
    1
    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 summarized in the first four columns 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 36 weeks).
    Adverse event reporting additional description
    For the fifth column, 'Total 2', this presents the data summarized in 'Total 1' PLUS adverse event data from the double-blind main study for subjects who received certolizumab pegol (CZP) in the main study and then entered this extension study (i.e., up to 44 weeks).
    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 (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 200 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Reporting group title
    CZP 400 mg / CZP 400 mg
    Reporting group description
    Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 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 (2014-004399-42)

    Reporting group title
    Total 1 (This extension study only)
    Reporting group description
    This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.

    Serious adverse events
    CZP 400 mg / Placebo CZP 400 mg / CZP 200 mg CZP 400 mg / CZP 400 mg Total 1 (This extension study only)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 13 (23.08%)
    4 / 15 (26.67%)
    8 / 46 (17.39%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    3 / 15 (20.00%)
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteomalacia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Electrolyte imbalance
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tetany
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Perianal abscess
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    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 200 mg CZP 400 mg / CZP 400 mg Total 1 (This extension study only)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 18 (83.33%)
    10 / 13 (76.92%)
    13 / 15 (86.67%)
    38 / 46 (82.61%)
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Injection site eyrthema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences all number
    0
    0
    1
    1
    Pyrexia
         subjects affected / exposed
    2 / 18 (11.11%)
    6 / 13 (46.15%)
    3 / 15 (20.00%)
    11 / 46 (23.91%)
         occurrences all number
    2
    9
    3
    14
    Swelling
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Psychiatric disorders
    Depressive symptom
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    0
    1
    Emotional distress
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    1
    0
    0
    1
    Initial insomnia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 46 (2.17%)
         occurrences all number
    0