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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study Evaluating the Efficacy and Safety of Ustekinumab (STELARA ® ) and CNTO 1959 Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy

    Summary
    EudraCT number
    		 2011-001122-18
    Trial protocol
    		 HU   CZ   BG  
    Global end of trial date
    05 May 2014

    Results information
    Results version number
    		 v1
    This version publication date
    06 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1275ARA2001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01645280
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340, Beerse, Belgium,
    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?
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    05 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of ustekinumab and CNTO 1959 in reducing signs and symptoms of disease in subjects with active Rheumatoid Arthritis [RA] despite concomitant methotrexate (MTX) therapy, and to evaluate the safety of ustekinumab and CNTO 1959 in this population.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Known instances of nonconformance were documented and are not considered to have had an impact on the overall conclusions of this study. The study protocol and amendment were reviewed by an Independent Ethics Committee (IEC) or Institutional Review Board (IRB). Safety assessments included monitoring and recording all adverse effects [AE] and serious adverse effects [SAE], laboratory evaluations (hematology, blood chemistry, urinalysis and immunogenicity), vital signs, body weight, electro cardio gram [ECG] and injection site reactions through Week 48.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jul 2012
    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
    Argentina: 23
    Country: Number of subjects enrolled
    Bulgaria: 9
    Country: Number of subjects enrolled
    Chile: 6
    Country: Number of subjects enrolled
    Colombia: 43
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Hungary: 19
    Country: Number of subjects enrolled
    Poland: 35
    Country: Number of subjects enrolled
    Russian Federation: 86
    Country: Number of subjects enrolled
    Singapore: 4
    Country: Number of subjects enrolled
    Ukraine: 46
    Country: Number of subjects enrolled
    United States: 1
    Worldwide total number of subjects
    273
    EEA total number of subjects
    64
    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)
    234
    From 65 to 84 years
    39
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 250 participants were planned, 274 were randomized, and 273 participants were treated.

    Pre-assignment
    Screening details
    		 Randomization was to be stratified by investigational site and by participant’s C-reactive protein (CRP) level at screening. Based on inclusion criteria of participants with screening CRP greater than or equal to (>=) 0.80 milligram per deciliter [mg/dL], it was assumed that 60 percent (%) to 80% of participants had CRP >=1.50 (mg/dL) at screening.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo+MTX
    Arm description
    		 At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

    Arm title
    		 Ustekinumab+MTX 90 mg q8w
    Arm description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose).

    Arm title
    		 Ustekinumab+MTX 90 mg q12w
    Arm description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 12 weeks with Methotrexate concomitant therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)

    Arm title
    		 CNTO1959+MTX 50 mg q8w
    Arm description
    		 CNTO1959 50 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)

    Arm title
    		 CNTO1959+MTX 200 mg q8w
    Arm description
    		 CNTO1959 200 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    CNTO 1959
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

    Number of subjects in period 1
    		Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Started
    55
    54
    55
    55
    54
    Completed
    50
    51
    50
    51
    50
    Not completed
    5
    3
    5
    4
    4
         Adverse event, serious fatal
    -
    1
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    1
    -
         Adverse event, non-fatal
    2
    -
    3
    2
    -
         Other
    1
    -
    -
    -
    -
         Lack of efficacy
    2
    2
    1
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo+MTX
    Reporting group description
    		 At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

    Reporting group title
    Ustekinumab+MTX 90 mg q8w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    Ustekinumab+MTX 90 mg q12w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 12 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 50 mg q8w
    Reporting group description
    		 CNTO1959 50 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 200 mg q8w
    Reporting group description
    		 CNTO1959 200 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group values
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w Total
    Number of subjects
    		 55 54 55 55 54 273
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0 0
        Adults (18-64 years)
    		 51 46 44 50 43 234
        From 65 to 84 years
    		 4 8 11 5 11 39
        85 years and over
    		 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.1 ( 10.57 ) 50.7 ( 13.13 ) 51.4 ( 13.59 ) 49.9 ( 12.85 ) 54.6 ( 11.34 ) -
    Title for Gender
    Units: subjects
        Female
    		 48 46 47 45 42 228
        Male
    		 7 8 8 10 12 45

    End points

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    End points reporting groups
    Reporting group title
    Placebo+MTX
    Reporting group description
    		 At Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)

    Reporting group title
    Ustekinumab+MTX 90 mg q8w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    Ustekinumab+MTX 90 mg q12w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 12 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 50 mg q8w
    Reporting group description
    		 CNTO1959 50 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 200 mg q8w
    Reporting group description
    		 CNTO1959 200 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Subject analysis set title
    Intent-to-treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The intent-to-treat (ITT) population included all randomized participants. For early escape, data at or prior to Week 16 were carried forward through Week 28.

    Primary: Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28

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    End point title
    		 Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 28
    End point description
    The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) patient's assessment of arthritis pain-visual analog scale, 2) patient's global assessment of disease activity-visual analog scale, 3) physician's global assessment of disease activity-visual analog scale, 4) patient’s assessment of physical function as measured by health assessment questionnaire-disability index (HAQ-Di), 5) C-reactive protein (CRP).
    End point type
    Primary
    End point timeframe
    Week 28
    End point values
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Number of subjects analysed
    55
    54
    55
    55
    54
    Units: percentage of participants
        number (not applicable)
    40
    52.7
    54.5
    38.2
    44.4
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.184
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Ustekinumab+MTX 90 mg q12w v Placebo+MTX
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.13
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 200 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.642
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 4
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 50 mg q8w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.832
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28

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    End point title
    		 Change From Baseline in Disease Activity Index Score 28 (DAS28; Using C-reactive Protein [CRP]) Score at Week 28
    End point description
    The DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, CRP milligram per liter (mG/L) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 28
    End point values
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Number of subjects analysed
    55
    54
    55
    55
    54
    Units: units on scale
        least squares mean (standard error)
    -0.94 ( 0.174 )
    -1.52 ( 0.185 )
    -1.49 ( 0.183 )
    6.07 ( 0.821 )
    -1.21 ( 0.17 )
    Statistical analysis title
    		 Statistical analysis 5
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.019
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 6
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q12w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 7
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 200 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.248
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 8
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 50 mg q8w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.045
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12

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    End point title
    		 Percentage of Participants With American College of Rheumatology 20 (ACR 20) Response at Week 12
    End point description
    The ACR 20 responders are participants with at least 20 percent (%) improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 2) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 3) Physician's Global Assessment of Disease Activity-Visual Analog Scale, 4) Patient’s Assessment of Physical Function as measured by Health Assessment Questionnaire-Disability Index (HAQ-DI), 5) C-reactive Protein (CRP).
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Number of subjects analysed
    55
    54
    55
    55
    54
    Units: percentage of participants
        number (not applicable)
    29.1
    37
    34.5
    20
    33.3
    Statistical analysis title
    		 Statistical analysis 9
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.381
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 10
    Comparison groups
    Ustekinumab+MTX 90 mg q12w v Placebo+MTX
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.543
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 11
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 200 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.629
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 12
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 50 mg q8w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.273
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28

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    End point title
    		 Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 28
    End point description
    The Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 28
    End point values
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Number of subjects analysed
    55
    54
    55
    55
    54
    Units: units on scale
        least squares mean (standard error)
    -0.3 ( 0.074 )
    -0.48 ( 0.072 )
    -0.44 ( 0.071 )
    -0.39 ( 0.076 )
    -0.41 ( 0.075 )
    Statistical analysis title
    		 Statistical analysis 13
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.06
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 14
    Comparison groups
    Placebo+MTX v Ustekinumab+MTX 90 mg q12w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.134
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 15
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 200 mg q8w
    Number of subjects included in analysis
    109
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.28
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Statistical analysis 16
    Comparison groups
    Placebo+MTX v CNTO1959+MTX 50 mg q8w
    Number of subjects included in analysis
    110
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.345
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Placebo+MTX
    Reporting group description
    		 Placebo with Methotrexate concomitant therapy

    Reporting group title
    Ustekinumab+MTX 90 mg q8w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    Ustekinumab+MTX 90 mg q12w
    Reporting group description
    		 Ustekinumab 90 mg by SC route at 0, 4 and 12 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 50 mg q8w
    Reporting group description
    		 CNTO1959 50 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Reporting group title
    CNTO1959+MTX 200 mg q8w
    Reporting group description
    		 CNTO1959 200 mg by SC route at 0, 4 and 8 weeks with Methotrexate concomitant therapy

    Serious adverse events
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 55 (7.27%)
    4 / 54 (7.41%)
    3 / 55 (5.45%)
    0 / 55 (0.00%)
    3 / 54 (5.56%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer Stage I
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Unstable
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rheumatoid Arthritis
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    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
    Lobar Pneumonia
         subjects affected / exposed
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Placebo+MTX Ustekinumab+MTX 90 mg q8w Ustekinumab+MTX 90 mg q12w CNTO1959+MTX 50 mg q8w CNTO1959+MTX 200 mg q8w
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 55 (32.73%)
    20 / 54 (37.04%)
    17 / 55 (30.91%)
    14 / 55 (25.45%)
    21 / 54 (38.89%)
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    2
    0
    0
    0
    1
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    2
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 55 (7.27%)
    4 / 54 (7.41%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
         occurrences all number
    4
    4
    2
    1
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 55 (5.45%)
    2 / 54 (3.70%)
    5 / 55 (9.09%)
    2 / 55 (3.64%)
    3 / 54 (5.56%)
         occurrences all number
    5
    3
    5
    2
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    3 / 54 (5.56%)
         occurrences all number
    1
    2
    0
    1
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
         occurrences all number
    1
    2
    1
    1
    1
    Influenza Like Illness
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 54 (3.70%)
    0 / 55 (0.00%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
         occurrences all number
    2
    2
    0
    2
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
    1 / 55 (1.82%)
    0 / 55 (0.00%)
    2 / 54 (3.70%)
         occurrences all number
    2
    1
    1
    0
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
    1 / 55 (1.82%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    2
    1
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    3 / 55 (5.45%)
    1 / 54 (1.85%)
         occurrences all number
    1
    0
    0
    4
    1
    Rheumatoid Arthritis
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    5 / 55 (9.09%)
    2 / 55 (3.64%)
    4 / 54 (7.41%)
         occurrences all number
    1
    2
    7
    2
    4
    Spinal Pain
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 54 (1.85%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
         occurrences all number
    2
    1
    2
    1
    0
    Tendonitis
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    0 / 55 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
         occurrences all number
    2
    0
    0
    0
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    2 / 55 (3.64%)
    2 / 55 (3.64%)
    4 / 54 (7.41%)
         occurrences all number
    1
    2
    2
    2
    5
    Influenza
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 54 (1.85%)
    3 / 55 (5.45%)
    3 / 55 (5.45%)
    3 / 54 (5.56%)
         occurrences all number
    4
    2
    3
    3
    4
    Nasopharyngitis
         subjects affected / exposed
    3 / 55 (5.45%)
    5 / 54 (9.26%)
    4 / 55 (7.27%)
    3 / 55 (5.45%)
    4 / 54 (7.41%)
         occurrences all number
    4
    8
    6
    6
    7
    Respiratory Tract Infection Viral
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 54 (0.00%)
    2 / 55 (3.64%)
    1 / 55 (1.82%)
    1 / 54 (1.85%)
         occurrences all number
    2
    0
    2
    2
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 55 (1.82%)
    2 / 54 (3.70%)
    2 / 55 (3.64%)
    2 / 55 (3.64%)
    2 / 54 (3.70%)
         occurrences all number
    2
    3
    2
    2
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Mar 2012
    The length of study was reduced to a 28-week placebo-controlled period with 20-week follow-up period. The hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) testings were added at the screening. The total blood volume was updated to include the additional laboratory testing added to the protocol. The treatment failure criteria were updated to include all reasons for discontinuation of study agent (such as due to adverse events [AEs]). A 12-lead ECG was added to the Week 28 safety evaluations. Instructions were added to the protocol to avoid unblinding by the Principal Investigator because of serious adverse events (SAEs) related to disease progression. Added that ribonucleic acid (RNA) would be measured from whole blood as well as serum in the study. The unit 10-cm was removed in reference to Visual Analogue Scale (VAS) since an electronic patient-reported outcome e-PRO) device was to be used to collect the VAS in the study. Preplanned surgery/procedure(s) row was removed from the time and events schedule since this row did not pertain to this study.

    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.
    No notable study limitations were identified by the Sponsor.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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