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    Clinical Trial Results:
    Multicenter, open label study to evaluate the predictability of early response to certolizumab pegol (in combination with methotrexate) as confirmed at week 52 in subjects with moderate-severe rheumatoid arthritis (RA)

    Summary
    EudraCT number
    2011-000385-35
    Trial protocol
    IT  
    Global end of trial date
    12 May 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    05 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RA0069
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01443364
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    UCB Pharma S.p.a.
    Sponsor organisation address
    Via Gadames 57, Milano, Italy, 20151
    Public contact
    Clinical Trial Registries and Results Disclosure, UCB BIOSCIENCES GmbH, +49 2173 48 15 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jul 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To detect the time-point of clinical response with the highest predictive value of long term efficacy (at Week 52).
    Protection of trial subjects
    Not applicable
    Background therapy
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    05 Dec 2011
    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
    Italy: 132
    Worldwide total number of subjects
    132
    EEA total number of subjects
    132
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    94
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study started to enroll patients in December 2011 and concluded in May 2015.

    Pre-assignment
    Screening details
    Participant Flow refers to all subjects randomized who have received at least one dose of study medication.

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

    Arms
    Arm title
    Certolizumab pegol
    Arm description
    Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
    Arm type
    Experimental

    Investigational medicinal product name
    Certolizumab pegol
    Investigational medicinal product code
    Cimzia
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pre-filled syringe with 1 ml of liquid at CZP dosage of 200 mg/ml

    Number of subjects in period 1
    Certolizumab pegol
    Started
    132
    Completed
    91
    Not completed
    41
         Other Reason
             4
         Lack of efficacy
             14
         SAE, non-fatal
             6
         SAE, non-fatal+AE, non-serious non-fatal
             1
         AE, non-serious non-fatal
             8
         Consent withdrawn by subject
             5
         Lost to follow-up
             3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Certolizumab pegol
    Reporting group description
    Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.

    Reporting group values
    Certolizumab pegol Total
    Number of subjects
    132 132
    Age Categorical
    Units: Subjects
        <=18 years
    0 0
        Between 18 and 65 years
    94 94
        >=65 years
    38 38
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    54.8 ± 13.2 -
    Gender Categorical
    Units: Subjects
        Female
    108 108
        Male
    24 24
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    35 35
        Not Hispanic or Latino
    97 97
    Weight
    Units: kilogram
        arithmetic mean (standard deviation)
    69.33 ± 14.1 -
    BMI
    Units: kg/m^2
        arithmetic mean (standard deviation)
    25.66 ± 4.52 -
    Height
    Units: centimeter
        arithmetic mean (standard deviation)
    164.16 ± 8.48 -

    End points

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    End points reporting groups
    Reporting group title
    Certolizumab pegol
    Reporting group description
    Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.

    Subject analysis set title
    Certolizumab pegol (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.

    Primary: The percentage of subjects with clinical response at Week 12 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 12 who also had clinical response at Week 52 [1]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 12 and Week 52
    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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    69.1 (58.78 to 78.27)
    No statistical analyses for this end point

    Primary: The percentage of subjects with clinical response at Week 8 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 8 who also had clinical response at Week 52 [2]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 8 and Week 52
    Notes
    [2] - 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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    69.8 (59.57 to 78.75)
    No statistical analyses for this end point

    Primary: The percentage of subjects with clinical response at Week 6 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 6 who also had clinical response at Week 52 [3]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 6 and Week 52
    Notes
    [3] - 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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    65.2 (54.33 to 74.96)
    No statistical analyses for this end point

    Primary: The percentage of subjects with clinical response at Week 4 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 4 who also had clinical response at Week 52 [4]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 4 and Week 52
    Notes
    [4] - 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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    66.7 (56.13 to 76.11)
    No statistical analyses for this end point

    Primary: The percentage of subjects with clinical response at Week 2 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 2 who also had clinical response at Week 52 [5]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 2 and Week 52
    Notes
    [5] - 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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    64.9 (52.89 to 75.61)
    No statistical analyses for this end point

    Primary: The percentage of subjects with clinical response at Week 1 who also had clinical response at Week 52

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    End point title
    The percentage of subjects with clinical response at Week 1 who also had clinical response at Week 52 [6]
    End point description
    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
    End point type
    Primary
    End point timeframe
    From Baseline to Week 1 and Week 52
    Notes
    [6] - 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
    Certolizumab pegol (FAS)
    Number of subjects analysed
    131
    Units: percentage of subjects
    number (confidence interval 95%)
        percentage of subjects
    55.8 (39.88 to 70.92)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 52

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 52
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-9 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 36

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 36
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-9 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 24

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 24
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-9 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 12

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 12
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 8

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 8
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 6

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 6
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-10 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 4

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 4
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-8 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 2

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 2
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-5 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the synovial fluid and proliferation at Week 1

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    End point title
    Change from Baseline in the synovial fluid and proliferation at Week 1
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 52

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 52
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 36

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 36
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-11 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 24

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 24
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-11 to 6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 12

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 12
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 8

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 8
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 6

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 6
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-12 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 4

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 4
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -0.5 (-10 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 2

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 2
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-10 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Doppler signal and blood flow at Week 1

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    End point title
    Change from Baseline in the Doppler signal and blood flow at Week 1
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-10 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 52

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    End point title
    Change from Baseline in the Cartilage damage at Week 52
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    55
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 8)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 36

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    End point title
    Change from Baseline in the Cartilage damage at Week 36
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    55
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-12 to 16)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 24

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    End point title
    Change from Baseline in the Cartilage damage at Week 24
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-13 to 11)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 12

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    End point title
    Change from Baseline in the Cartilage damage at Week 12
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 11)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 8

    Close Top of page
    End point title
    Change from Baseline in the Cartilage damage at Week 8
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 6

    Close Top of page
    End point title
    Change from Baseline in the Cartilage damage at Week 6
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 7)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 4

    Close Top of page
    End point title
    Change from Baseline in the Cartilage damage at Week 4
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 2

    Close Top of page
    End point title
    Change from Baseline in the Cartilage damage at Week 2
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-11 to 9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Cartilage damage at Week 1

    Close Top of page
    End point title
    Change from Baseline in the Cartilage damage at Week 1
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    50
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-8 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 52

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 52
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 36

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 36
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 24

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 24
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 10)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 12

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 12
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 8

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 8
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 6

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 6
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 4

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 4
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-5 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 2

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 2
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-4 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the bone erosion at Week 1

    Close Top of page
    End point title
    Change from Baseline in the bone erosion at Week 1
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (-4 to 2)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -3 (-20 to 5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -3 (-20 to 6)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -3 (-20 to 10)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -3 (-23 to 14)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -3 (-23 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2.5 (-20 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    58
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2.5 (-17 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-13 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1

    Close Top of page
    End point title
    Change from Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-13 to 3)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    55
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-15 to 9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    55
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-15 to 17)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1.5 (-15 to 10)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-15 to 11)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-13 to 11)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -2 (-15 to 5)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    54
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-15 to 4)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    53
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-15 to 9)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1

    Close Top of page
    End point title
    Change from Baseline in the sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    50
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    -1 (-10 to 4)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 52

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 52
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 16)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 36

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 36
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 16)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 24

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 24
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 16)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 12

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 12
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 13)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 8

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 8
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 14)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 6

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 6
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6 (0 to 12)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 4

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 4
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6 (0 to 13)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 2

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 2
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    7 (0 to 12)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 1

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 1
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    7 (1 to 13)
    No statistical analyses for this end point

    Secondary: Synovial fluid and proliferation at Week 0

    Close Top of page
    End point title
    Synovial fluid and proliferation at Week 0
    End point description
    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 15)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 52

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 52
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (0 to 10)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 36

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 36
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (0 to 10)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 24

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 24
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (0 to 10)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 12

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 12
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (0 to 12)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 8

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 8
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0 (0 to 7)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 6

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 6
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    0.5 (0 to 7)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 4

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 4
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 9)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 2

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 2
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    1 (0 to 11)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 1

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 1
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    1 (0 to 11)
    No statistical analyses for this end point

    Secondary: Doppler signal and blood flow at Week 0

    Close Top of page
    End point title
    Doppler signal and blood flow at Week 0
    End point description
    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints). A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 12)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 52

    Close Top of page
    End point title
    Cartilage damage at Week 52
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4 (0 to 20)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 36

    Close Top of page
    End point title
    Cartilage damage at Week 36
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 24)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 24

    Close Top of page
    End point title
    Cartilage damage at Week 24
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4.5 (0 to 19)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 12

    Close Top of page
    End point title
    Cartilage damage at Week 12
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 20)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 8

    Close Top of page
    End point title
    Cartilage damage at Week 8
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4.5 (0 to 20)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 6

    Close Top of page
    End point title
    Cartilage damage at Week 6
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4 (0 to 20)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 4

    Close Top of page
    End point title
    Cartilage damage at Week 4
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4 (0 to 20)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 2

    Close Top of page
    End point title
    Cartilage damage at Week 2
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    61
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    4 (0 to 21)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 1

    Close Top of page
    End point title
    Cartilage damage at Week 1
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 21)
    No statistical analyses for this end point

    Secondary: Cartilage damage at Week 0

    Close Top of page
    End point title
    Cartilage damage at Week 0
    End point description
    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    56
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6 (0 to 21)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 52

    Close Top of page
    End point title
    Bone erosion at Week 52
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 10)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 36

    Close Top of page
    End point title
    Bone erosion at Week 36
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 11)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 24

    Close Top of page
    End point title
    Bone erosion at Week 24
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 11)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 12

    Close Top of page
    End point title
    Bone erosion at Week 12
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 10)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 8

    Close Top of page
    End point title
    Bone erosion at Week 8
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 10)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 6

    Close Top of page
    End point title
    Bone erosion at Week 6
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 10)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 4

    Close Top of page
    End point title
    Bone erosion at Week 4
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 10)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 2

    Close Top of page
    End point title
    Bone erosion at Week 2
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 15)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 1

    Close Top of page
    End point title
    Bone erosion at Week 1
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 15)
    No statistical analyses for this end point

    Secondary: Bone erosion at Week 0

    Close Top of page
    End point title
    Bone erosion at Week 0
    End point description
    The bone erosion is a semiquantitative score (0-4 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    60
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    2 (0 to 15)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    5 (0 to 26)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6 (0 to 26)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6.5 (0 to 26)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    7 (0 to 22)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    6 (0 to 16)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    7 (0 to 16)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 18)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 23)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (1 to 23)
    No statistical analyses for this end point

    Secondary: Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0

    Close Top of page
    End point title
    Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0
    End point description
    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6) on each of 6 joints. A greater score indicates greater disease activity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    59
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    10 (1 to 24)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52

    Close Top of page
    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 52
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    7 (0 to 38)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36

    Close Top of page
    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 36
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    65
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 38)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 24
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    10 (0 to 38)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 12
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    9 (0 to 38)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 8
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 8
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    64
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    9 (0 to 34)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 6
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 33)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 4
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    63
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    8 (0 to 34)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 2
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    61
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    10 (0 to 43)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 1
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    57
    Units: units on a scale
    median (full range (min-max))
        median (full range)
    10 (0 to 47)
    No statistical analyses for this end point

    Secondary: Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 0

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    End point title
    Sum of the progression in the Doppler signal, cartilage damage and bone erosion score at Week 0
    End point description
    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints). A greater score indicates greater disease severity.
    End point type
    Secondary
    End point timeframe
    Week 0 (Baseline)
    End point values
    Certolizumab pegol (FAS)
    Number of subjects analysed
    55
    Units: units on a scale
    median (full range (min-max))
        mean (standard deviation)
    12 (0 to 47)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
    Adverse event reporting additional description
    Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Certolizumab pegol
    Reporting group description
    Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.

    Serious adverse events
    Certolizumab pegol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 132 (12.12%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lobular breast carcinoma in situ
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Genital prolapse
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Retroperitoneal lymphadenopathy
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sinus disorder
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Anosmia
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    Periorbital oedema
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Bladder prolapse
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder mass
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Paratyphoid fever
         subjects affected / exposed
    1 / 132 (0.76%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Certolizumab pegol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 132 (23.48%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    7 / 132 (5.30%)
         occurrences all number
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    9 / 132 (6.82%)
         occurrences all number
    18
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 132 (5.30%)
         occurrences all number
    7
    Influenza
         subjects affected / exposed
    15 / 132 (11.36%)
         occurrences all number
    16

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Jul 2011
    Protocol Amendment 1, dated 07 Jul 2011, was implemented after the central ethics committee review of the initial protocol, when changes were deemed necessary for conduct of this study in Italy. This amendment occurred prior to inclusion of subjects. The following changes were made throughout the protocol: • Quality of Life assessments were altered (eg, removal of PRISM test, Euro QoL-5D changed to EQ-5D-3L). • Evaluation of healthcare use’ was added as an exploratory objective (and accordingly was added in list of other efficacy variables and concomitant procedures). • Laboratory assessments were centralized, except for ESR, TB and urine pregnancy testing.
    07 Jul 2011
    • Safety reporting was updated, with extension of the follow up period from 30 days to 10 weeks, and clarification that a serious AE (SAE) or an AE leading to premature discontinuation from the study had to be followed up until it had resolved, stabilized or the Investigator no longer felt it was clinically significant; TB and ischemic cardiac events were added to AEs of interest list; the anticipated AE list was removed. • Biomarkers assessments were updated (Week 0 assessment changed to Week -2). • Immunological assessments were updated (Week -2 assessment deleted, and Weeks 0, 2, 6, 12, and 36 assessments added to text). • For pregnancy testing and x-ray assessment, previously missing text was added (to correspond with schedule). • An explanation was added that EQ-5D-3L dimensions scores, VAS actual scores, and healthcare resource utilization scores would be summarized using descriptive statistics. • Previously termed ‘anticipated AEs’ in Appendices were renamed ‘predicted AEs,’ and those for CZP added. • Inclusion criterion number 9 was changed from ‘Subject is naïve or has received up to 1 prior anti-TNF therapy, which was not discontinued due to primary failure’ to ‘Subject is naïve to RA related biologics (eg, anti-TNF therapy). • Exclusion criteria numbers 13 to 17 regarding prior treatments were replaced with ‘Subject has received previous RA related biologics therapy (eg, anti-TNF)’.
    24 Oct 2011
    Protocol Amendment 2, dated 24 Oct 2011, was implemented after the Sponsor discussed the subgroup analysis with other experts. It was decided to remove the MRI assessments: although the use of gadolinium would have resulted in better data, this invasive method could have been a limiting factor and restrict recruitment. Lack of interest in MRI assessments at investigational sites also contributed to this decision. It was agreed that remaining methods would still provide sufficient data to monitor the response of joint synovitis and to investigate the predictability of an early sonography response for long-term response. The MRI Assessment was therefore removed from all applicable sections. In addition, clarification was added that methotrexate should be taken throughout the study without discontinuation, and that no dose adjustment was allowed except for documented intolerance or toxicity. This amendment was approved after one subject had been screened.
    06 Mar 2013
    Protocol Amendment 3, dated 06 Mar 2013, was implemented after to clarify objectives and endpoints of the study, to add a second reading of US images for the purpose of assessing interreader variability, to align the protocol with UCB standards in terms of definitions, naming conventions, and procedures, and to streamline the planned data analysis in alignment with the objectives. Specifically: • The secondary objective was modified to allow for more general conclusions on the results of US assessments; assessment of the changes in CRP and ESR were replaced with assessment of the relationship between US response and clinical response over time. • Endpoints were shifted in the appropriate sections in alignment with the objectives; in particular, CRP and ESR were moved to the Other Efficacy section. • The procedure of the analysis of US images was amended to allow for an assessment of interobserver reliability. • Clarifications and definitions were added to specify the study conduct and procedures.
    06 Mar 2013
    • Definitions were updated to be consistent with UCB standards (eg, specifications of tuberculosis [TB] assessments and the TEAE definition). • Study timelines were amended according to new forecasts. • Rescreening of subjects was allowed for screen-failed subjects. The following additional changes were made throughout the protocol: • The upper limit of the category Low Disease Activity was changed from <3.2 to ≤3.2. • The definition of clinical response based on DAS28-ESR was changed from a reduction of >1.2 scores in the DAS28-ESR to a reduction of ≥1.2 scores in the DAS28-ESR. • The Health assessment questionnaire (HAQ) was renamed Health Assessment Questionnaire Disability Index (HAQ-DI). • The term Investigator’s Assessment of Disease Activity (IGA) was changed to Physician’s Assessment of Disease Activity (PhGADA). • The abbreviation of Patient’s Assessment of Disease Activity (PGA) was changed to PtGADA. • The word parameter was replaced by the word variable. • HBV DNA requirements were clarified.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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