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    Clinical Trial Results:
    A Phase 2 Multicenter, Randomized, Placebo- and Active-Comparator-Controlled, Dose-Ranging Trial to Evaluate CNTO1959 for the Treatment of Subjects with Moderate to Severe Plaque-type Psoriasis (X-PLORE)

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2011-001066-17
    Trial protocol
    DE   BE  
    Global end of trial date
    05 Aug 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    15 Aug 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO1959PSO2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01483599
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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
    20 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the efficacy and safety of CNTO 1959 in the treatment of participants with moderate to severe plaque psoriasis.
    Protection of trial subjects
    Safety evaluation of this study included physical examinations, detection of injection site and allergic reactions, electrocardiograms (ECGs), clinical laboratory tests, vital signs and concomitant medications. Safety was to be monitored through Week 52 for all participants. Adverse events (AEs) were reported throughout the study period.
    Background therapy
    None
    Evidence for comparator
    Adalimumab: Particpants receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to Week 39 as active comparator.
    Actual start date of recruitment
    25 Oct 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    Canada: 83
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Poland: 55
    Country: Number of subjects enrolled
    United States: 127
    Worldwide total number of subjects
    293
    EEA total number of subjects
    83
    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)
    272
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 394 participants were screened, however 293 participants were randomized to receive treatment.

    Period 1
    Period 1 title
    Controlled period (Week 0 - 16)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo (CP)
    Arm description
    Participants received placebo at Week 0, 4 and 8.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received placebo at Week 0, 4 and 8.

    Arm title
    5 mg CNTO1959 (CP)
    Arm description
    Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

    Arm title
    15 mg CNTO1959 (CP)
    Arm description
    Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

    Arm title
    50 mg CNTO1959 (CP)
    Arm description
    Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

    Arm title
    100 mg CNTO1959 (CP)
    Arm description
    Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

    Arm title
    200 mg CNTO1959 (CP)
    Arm description
    Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

    Arm title
    Adalimumab (CP)
    Arm description
    Adalimumab (Week 0 - 16, Open label): Participants received Adalimumab 80 milligram (mg) as open label at week 0 followed by 40 mg at week 1 and every second week up to week 15. Efficacy for this arm was evaluated by a blinded assessor.
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received Adalimumab 80 milligram (mg) at week 0 followed by 40 mg at week 1 and every second week up to week 15 (i.e., Weeks 3, 5, 7, etc.)

    Number of subjects in period 1
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP)
    Started
    42
    41
    41
    42
    42
    42
    43
    Completed
    39
    38
    41
    39
    40
    38
    39
    Not completed
    3
    3
    0
    3
    2
    4
    4
         Other
    -
    2
    -
    1
    1
    -
    -
         Lack of efficacy
    1
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    2
    -
    -
    1
    1
    4
    3
         Lost to follow-up
    -
    1
    -
    1
    -
    -
    1
    Period 2
    Period 2 title
    After Controlled period (Week 16 - 52)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo --> 100 mg CNTO1959 (after CP)
    Arm description
    Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.

    Arm title
    5 mg CNTO1959 (after CP)
    Arm description
    Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.

    Arm title
    15 mg CNTO1959 (after CP)
    Arm description
    Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.

    Arm title
    50 mg CNTO1959 (after CP)
    Arm description
    Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.

    Arm title
    100 mg CNTO1959 (after CP)
    Arm description
    Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.

    Arm title
    200 mg CNTO1959 (after CP)
    Arm description
    Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.
    Arm type
    Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.

    Arm title
    Adalimumab (after CP)
    Arm description
    Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)
    Arm type
    Experimental

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)

    Number of subjects in period 2
    Placebo --> 100 mg CNTO1959 (after CP) 5 mg CNTO1959 (after CP) 15 mg CNTO1959 (after CP) 50 mg CNTO1959 (after CP) 100 mg CNTO1959 (after CP) 200 mg CNTO1959 (after CP) Adalimumab (after CP)
    Started
    39
    38
    41
    39
    40
    38
    39
    Completed
    37
    29
    37
    37
    39
    35
    32
    Not completed
    2
    9
    4
    2
    1
    3
    7
         Other
    1
    -
    4
    -
    -
    1
    -
         Lack of efficacy
    -
    5
    -
    -
    -
    1
    4
         Adverse event, serious fatal
    -
    1
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    1
    1
    -
    -
    -
    1
    1
         Consent withdrawn by subject
    -
    1
    -
    2
    -
    -
    1
         Lost to follow-up
    -
    1
    -
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (CP)
    Reporting group description
    Participants received placebo at Week 0, 4 and 8.

    Reporting group title
    5 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

    Reporting group title
    15 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

    Reporting group title
    50 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

    Reporting group title
    100 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

    Reporting group title
    200 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

    Reporting group title
    Adalimumab (CP)
    Reporting group description
    Adalimumab (Week 0 - 16, Open label): Participants received Adalimumab 80 milligram (mg) as open label at week 0 followed by 40 mg at week 1 and every second week up to week 15. Efficacy for this arm was evaluated by a blinded assessor.

    Reporting group values
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP) Total
    Number of subjects
    42 41 41 42 42 42 43 293
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0
        Adults (18-64 years)
    41 40 39 41 36 40 35 272
        From 65 to 84 years
    1 1 2 1 6 2 8 21
        85 years and over
    0 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    45 ± 11.97 45.2 ± 13.92 43.8 ± 13.5 42.6 ± 12.14 45.3 ± 13.72 45.1 ± 10.96 47.5 ± 14.91 -
    Title for Gender
    Units: subjects
        Female
    14 13 13 12 10 11 13 86
        Male
    28 28 28 30 32 31 30 207

    End points

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    End points reporting groups
    Reporting group title
    Placebo (CP)
    Reporting group description
    Participants received placebo at Week 0, 4 and 8.

    Reporting group title
    5 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 5 milligram (mg) subcutaneously at Weeks 0 and 4.

    Reporting group title
    15 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 15 milligram (mg) subcutaneously at Weeks 0 and 8.

    Reporting group title
    50 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 50 milligram (mg) subcutaneously at weeks 0 and 4.

    Reporting group title
    100 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 100 milligram (mg) subcutaneously at weeks 0 and 8.

    Reporting group title
    200 mg CNTO1959 (CP)
    Reporting group description
    Participants received CNTO1959 200 milligram (mg) subcutaneously at weeks 0 and 4.

    Reporting group title
    Adalimumab (CP)
    Reporting group description
    Adalimumab (Week 0 - 16, Open label): Participants received Adalimumab 80 milligram (mg) as open label at week 0 followed by 40 mg at week 1 and every second week up to week 15. Efficacy for this arm was evaluated by a blinded assessor.
    Reporting group title
    Placebo --> 100 mg CNTO1959 (after CP)
    Reporting group description
    Participants received 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40.

    Reporting group title
    5 mg CNTO1959 (after CP)
    Reporting group description
    Participants received CNTO1959 5 milligram (mg) subcutaneously at week 16, then every 12 weeks through Week 40.

    Reporting group title
    15 mg CNTO1959 (after CP)
    Reporting group description
    Participants received CNTO1959 15 milligram (mg) subcutaneously at week 16 and then every 8 weeks through Week 40.

    Reporting group title
    50 mg CNTO1959 (after CP)
    Reporting group description
    Participants received CNTO1959 50 mg subcutaneously at week 16, then every 12 weeks through Week 40.

    Reporting group title
    100 mg CNTO1959 (after CP)
    Reporting group description
    Participants received CNTO1959 100 milligram (mg) subcutaneously at week 16, then every 8 weeks through Week 40.

    Reporting group title
    200 mg CNTO1959 (after CP)
    Reporting group description
    Participants received CNTO1959 200 mg subcutaneously at week 16, then every 12 weeks through Week 40.

    Reporting group title
    Adalimumab (after CP)
    Reporting group description
    Participants received Adalimumab 40 milligram (mg) at week 17 and every second week through Week 39 (i.e., Weeks 19, 21, 23, etc.)

    Subject analysis set title
    Randomised Population
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All randomized subjects were analyzed according to their assigned treatment group regardless of the actual treatment received (ie, adalimumab, placebo, CNTO 1959). For subjects randomized to placebo, only subjects who crossed over to receive CNTO 1959 100 mg q8w at Week 16 were included in the efficacy summaries after Week 16.

    Primary: Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16

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    End point title
    Number of Participants With Cleared or Minimal (0 or 1) Physician's Global Assessment (PGA) Score at Week 16
    End point description
    Percentage of participants with cleared or minimal (0 or 1) at Week 16 was reported. The PGA score is a numeric scale which is completed by the physician and was designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions will be graded as: 0=cleared, 1=minimal, 2=mild, 3=moderate,4=marked, and 5=severe.
    End point type
    Primary
    End point timeframe
    Up to Week 16
    End point values
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP)
    Number of subjects analysed
    42 [1]
    41 [2]
    41 [3]
    42 [4]
    42 [5]
    42 [6]
    43 [7]
    Units: Participants
    3
    14
    25
    33
    36
    35
    25
    Notes
    [1] - Randomised Population
    [2] - Randomised Population
    [3] - Randomised Population
    [4] - Randomised Population
    [5] - Randomised Population
    [6] - Randomised Population
    [7] - Randomised Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (CP) v 5 mg CNTO1959 (CP)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (CP) v 15 mg CNTO1959 (CP)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (CP) v 50 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (CP) v 100 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    Placebo (CP) v 200 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score

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    End point title
    Number of Participants With 75 Percent (%) Improvement in Psoriasis Area and Severity Index (PASI) Score
    End point description
    Percentage of participants with >=75% improvement in PASI score at Week 16 from Baseline was reported. PASI is a widely used tool for the measurement of severity of psoriasis. The combination of redness, scaling, and thickness, as well as overall body involvement determine the PASI score. The scale ranges from 0 (best) to 72 (worst).
    End point type
    Secondary
    End point timeframe
    Up to week 16
    End point values
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP)
    Number of subjects analysed
    42 [8]
    41 [9]
    41 [10]
    42 [11]
    42 [12]
    42 [13]
    43 [14]
    Units: Participants
    2
    18
    31
    34
    33
    34
    30
    Notes
    [8] - Randomised Population
    [9] - Randomised Population
    [10] - Randomised Population
    [11] - Randomised Population
    [12] - Randomised Population
    [13] - Randomised Population
    [14] - Randomised Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (CP) v 5 mg CNTO1959 (CP)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [15]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [15] - p-Value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (CP) v 15 mg CNTO1959 (CP)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [16]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [16] - P-value was based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (CP) v 50 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [17]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [17] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (CP) v 100 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [18]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [18] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).
    Statistical analysis title
    Statistical Analysis 5
    Comparison groups
    Placebo (CP) v 200 mg CNTO1959 (CP)
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [19]
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [19] - P-value is based on the Cochran-Mantel-Haenszel chi-square test stratified by baseline weight (≤ 90 kg, > 90 kg).

    Secondary: Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40

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    End point title
    Percentage of Participants Achieving the Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 16 and Week 40 [20]
    End point description
    Difference and the 95% confidence intervals in the percentage of participants achieving a PGA score of cleared (0) or minimal (1) at Week 16 and Week 40 between each of the CNTO 1959 treatment groups and the adalimumab treatment group was calculated. The PGA score is a numeric scale which was completed by the physician and was designed to evaluate the physician's overall assessment of the participant's psoriasis. Overall lesions was graded as: 0=cleared, 1=minimal, 2=mild, 3=moderate,4=marked, and 5=severe. The proportion of subjects achieving a PGA score of cleared (0) or minimal (1) was lower in theCNTO 1959 5 mg q12w group as compared with the adalimumab group, however the 95% CI incudes 0. Here 'n' signifies the number of participants evaluated at this time point.
    End point type
    Secondary
    End point timeframe
    Weeks 16 and 40
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Subjects randomized in placebo group were not evaluated for this endpoint.
    End point values
    5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP)
    Number of subjects analysed
    41
    41
    42
    42
    42
    43
    Units: `Percentage of participants
    number (confidence interval 95%)
        Week 16 (n=41, 41, 42, 42, 42, 43)
    -24 (-44 to -4)
    2.8 (-17.9 to 23.5)
    20.4 (1.5 to 39.3)
    27.7 (9.8 to 45.6)
    25.4 (7.2 to 43.6)
    0 (0 to 0)
        Week 40 (n=34, 37, 38, 39, 37,37)
    -15.4 (-37.7 to 6.9)
    10.8 (-10.7 to 32.4)
    22.7 (1.8 to 43.6)
    28.7 (8.5 to 49)
    32.9 (13 to 52.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16

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    End point title
    Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16
    End point description
    The DLQI is a self-administered 10-item questionnaire that is used to assess 6 different aspects of quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Scores range from 0 (no impairment in quality of life) to 30 (most impairment in quality of life).
    End point type
    Secondary
    End point timeframe
    Up to week 16
    End point values
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP)
    Number of subjects analysed
    42 [21]
    39 [22]
    41 [23]
    40 [24]
    40 [25]
    39 [26]
    39 [27]
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -2.3 ± 6.8
    -6.2 ± 5.24
    -10.3 ± 5.49
    -11.1 ± 7.38
    -10.8 ± 7.34
    -11.4 ± 6.83
    -10.1 ± 9
    Notes
    [21] - Randomised Population
    [22] - Randomised Population
    [23] - Randomised Population
    [24] - Randomised Population
    [25] - Randomised Population
    [26] - Randomised Population
    [27] - Randomised Population
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo (CP) v 5 mg CNTO1959 (CP)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.008 [28]
    Method
    ANOVA
    Confidence interval
    Notes
    [28] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo (CP) v 15 mg CNTO1959 (CP)
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [29]
    Method
    ANOVA
    Confidence interval
    Notes
    [29] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Placebo (CP) v 50 mg CNTO1959 (CP)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [30]
    Method
    ANOVA
    Confidence interval
    Notes
    [30] - P-value was based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo (CP) v 100 mg CNTO1959 (CP)
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001 [31]
    Method
    ANOVA
    Confidence interval
    Notes
    [31] - P-value is based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.
    Statistical analysis title
    Statistical analysis 5
    Comparison groups
    200 mg CNTO1959 (CP) v Placebo (CP)
    Number of subjects included in analysis
    81
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001 [32]
    Method
    ANOVA
    Confidence interval
    Notes
    [32] - P-value is based on the analysis of variance (ANOVA) on the van der Waerden normal scores adjusted with baseline weight (≤90 kg, >90 kg) as a binary covariate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to followup (Week 52)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Placebo (CP)
    Reporting group description
    Placebo (Week 0 - 16): Placebo SC administration at Week 0, Week 4, and Week 8

    Reporting group title
    5 mg CNTO1959 (CP)
    Reporting group description
    5 mg CNTO 1959 (Week 0 - 16): 5 mg CNTO1959 SC administration at Week 0 and Week 4

    Reporting group title
    15 mg CNTO1959 (CP)
    Reporting group description
    15 mg CNTO1959 (Week 0 - 16): 15 mg CNTO1959 SC administration at Week 0 and Week 8

    Reporting group title
    50 mg CNTO1959 (CP)
    Reporting group description
    50 mg CNTO1959 (Week 0 - 16): 50 mg CNTO1959 SC administration at Week 0 and Week 4

    Reporting group title
    100 mg CNTO1959 (CP)
    Reporting group description
    100 mg CNTO1959 (Week 0 - 16): 100 mg CNTO1959 SC administration at Week 0 and Week 8

    Reporting group title
    200 mg CNTO1959 (CP)
    Reporting group description
    200 mg CNTO1959 (Week 0 - 16): 200 mg CNTO1959 SC administration at Week 0 and Week 4

    Reporting group title
    Adalimumab (CP)
    Reporting group description
    Adalimumab (Week 0 - 16): Patients receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to week 15

    Reporting group title
    Placebo --> 100 mg CNTO1959 (after CP)
    Reporting group description
    Placebo --> 100 mg CNTO1959 (Week 16 - 40): Patients receiving Placebo at Week 0, 4, and week 8 --> receiving 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

    Reporting group title
    5 mg CNTO1959 (after CP)
    Reporting group description
    5 mg CNTO1959 (after CP): patients receiving 5 mg CNTO1959 at Week 0 and 4 --> receiving 5 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

    Reporting group title
    15 mg CNTO1959 (after CP)
    Reporting group description
    15 mg CNTO1959 (after CP): patients receiving 15 mg CNTO1959 at Week 0 and 8 --> receiving 15 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

    Reporting group title
    50 mg CNTO1959 (after CP)
    Reporting group description
    50 mg CNTO1959 (after CP): patients receiving 50 mg CNTO1959 at Week 0 and 4 --> receiving 50 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

    Reporting group title
    100 mg CNTO1959 (after CP)
    Reporting group description
    100 mg CNTO1959 (after CP): patients receiving 100 mg CNTO1959 at Week 0 and 8 --> receiving 100 mg CNTO1959 at Week 16 and every 8 weeks (q8w) thereafter through Week 40

    Reporting group title
    200 mg CNTO1959 (after CP)
    Reporting group description
    200 mg CNTO1959 (after CP): patients receiving 200 mg CNTO1959 at Week 0 and 4 --> receiving 200 mg CNTO1959 at Week 16 and every 12 weeks (q12w) thereafter through Week 40

    Reporting group title
    Adalimumab (after CP)
    Reporting group description
    Adalimumab (after CP): Patients receiving 80 mg adalimumab at Week 0, 40 mg at Week 1 and every other week to week 15 --> receiving 40 mg adalimumab at week 17 and every other week through Week 39

    Serious adverse events
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP) Placebo --> 100 mg CNTO1959 (after CP) 5 mg CNTO1959 (after CP) 15 mg CNTO1959 (after CP) 50 mg CNTO1959 (after CP) 100 mg CNTO1959 (after CP) 200 mg CNTO1959 (after CP) Adalimumab (after CP)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    3 / 42 (7.14%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
    2 / 38 (5.26%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Flutter
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oesophagitis Haemorrhagic
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine Prolapse
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    1 / 38 (2.63%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo (CP) 5 mg CNTO1959 (CP) 15 mg CNTO1959 (CP) 50 mg CNTO1959 (CP) 100 mg CNTO1959 (CP) 200 mg CNTO1959 (CP) Adalimumab (CP) Placebo --> 100 mg CNTO1959 (after CP) 5 mg CNTO1959 (after CP) 15 mg CNTO1959 (after CP) 50 mg CNTO1959 (after CP) 100 mg CNTO1959 (after CP) 200 mg CNTO1959 (after CP) Adalimumab (after CP)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 42 (30.95%)
    15 / 41 (36.59%)
    10 / 41 (24.39%)
    10 / 42 (23.81%)
    7 / 42 (16.67%)
    8 / 41 (19.51%)
    10 / 43 (23.26%)
    16 / 39 (41.03%)
    12 / 38 (31.58%)
    4 / 41 (9.76%)
    11 / 39 (28.21%)
    16 / 40 (40.00%)
    12 / 38 (31.58%)
    13 / 39 (33.33%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    3 / 42 (7.14%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    4
    1
    1
    0
    1
    0
    0
    1
    2
    1
    1
    Injury, poisoning and procedural complications
    Muscle Strain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 43 (2.33%)
    2 / 39 (5.13%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    2 / 41 (4.88%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    2 / 38 (5.26%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    0
    0
    3
    0
    0
    0
    0
    0
    1
    2
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    1 / 42 (2.38%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    1 / 38 (2.63%)
    0 / 41 (0.00%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences all number
    1
    3
    4
    1
    2
    0
    0
    1
    2
    0
    1
    2
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 42 (4.76%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences all number
    3
    1
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Influenza Like Illness
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Injection Site Erythema
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    5 / 43 (11.63%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    1
    0
    0
    0
    1
    6
    18
    0
    0
    0
    0
    0
    0
    12
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    4
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    2 / 43 (4.65%)
    3 / 39 (7.69%)
    2 / 38 (5.26%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    1 / 40 (2.50%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    0
    1
    1
    1
    2
    4
    2
    0
    0
    1
    1
    1
    Back Pain
         subjects affected / exposed
    0 / 42 (0.00%)
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
    0 / 38 (0.00%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    0 / 39 (0.00%)
         occurrences all number
    0
    3
    1
    0
    2
    0
    0
    0
    0
    1
    1
    2
    1
    0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    2 / 39 (5.13%)
    1 / 38 (2.63%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    4
    1
    0
    0
    2
    1
    1
    Influenza
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
    0 / 38 (0.00%)
    0 / 41 (0.00%)
    0 / 39 (0.00%)
    2 / 40 (5.00%)
    1 / 38 (2.63%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    2
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 42 (2.38%)
    6 / 41 (14.63%)
    4 / 41 (9.76%)
    1 / 42 (2.38%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    2 / 43 (4.65%)
    4 / 39 (10.26%)
    6 / 38 (15.79%)
    1 / 41 (2.44%)
    7 / 39 (17.95%)
    4 / 40 (10.00%)
    5 / 38 (13.16%)
    6 / 39 (15.38%)
         occurrences all number
    1
    6
    4
    1
    1
    2
    2
    4
    8
    1
    7
    5
    11
    7
    Sinusitis
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    0 / 43 (0.00%)
    2 / 39 (5.13%)
    1 / 38 (2.63%)
    1 / 41 (2.44%)
    1 / 39 (2.56%)
    0 / 40 (0.00%)
    0 / 38 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    1
    2
    0
    0
    2
    1
    1
    1
    0
    0
    0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 42 (2.38%)
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
    0 / 42 (0.00%)
    3 / 41 (7.32%)
    2 / 43 (4.65%)
    4 / 39 (10.26%)
    4 / 38 (10.53%)
    1 / 41 (2.44%)
    0 / 39 (0.00%)
    3 / 40 (7.50%)
    2 / 38 (5.26%)
    3 / 39 (7.69%)
         occurrences all number
    1
    3
    0
    2
    0
    3
    2
    5
    5
    1
    0
    4
    2
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Sep 2011
    The first amendment was implemented before the study was initiated, and included the following changes: addition of an exclusion criterion regarding the use of anti-TNFα agents, clarification of the reference time point for receiving treatments targeted to IL -12, IL 17A, or IL 23 in inclusion/exclusion criteria, updating of exclusion criterion regarding time frame for receiving live vaccines, removal of interactive voice response system (IVRS) as a method of collecting unblinding information, clarification of the time frame for the observation for severe allergic reactions, and other minor editorial changes.
    27 Feb 2012
    The second amendment included the following changes: an inclusion criterion was updated to allow entry of participants willing to receive adalimumab injections by a care provider at home, the exclusion criterion requiring participants not to have a known history of human immunodeficiency virus (HIV) was updated to require documentation of a negative HIV test prior to enrollment. In addition, text was added to clarify the exact duration of sample storage, the Sponsor’s name was changed from Centocor to Janssen Research & Development, and other minor editorial changes.

    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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