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    Clinical Trial Results:
    A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL®) or Adalimumab (HUMIRA®)

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-010582-23
    Trial protocol
    DE   BE   AT   SE   GR   IT   GB  
    Global end of trial date
    03 Oct 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    16 Jul 2016
    First version publication date
    30 Jul 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
    CNTO148ART3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01004432
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Biologics B.V.
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen Biologics B.V., clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Biologics B.V., 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
    03 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of Golimumab + Methotrexate (MTX) in reducing signs and symptoms of Rheumatoid Arthritis (RA) (as assessed by the American College of Rheumatology [ACR] 20) at Week 14 in Participants with inadequate disease control despite treatment with etanercept + MTX or adalimumab + MTX.
    Protection of trial subjects
    Safety evaluations included physical examinations, vital sign measurements, chest x-ray, tuberculosis (TB) testing, pregnancy tests, urinalysis, routine laboratory tests, and tests for hepatitis B virus (HBV) infection, as well as monitoring concomitant medications and adverse events (including injection-site reactions and infusion reactions).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    29 Oct 2009
    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
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Canada: 37
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Sweden: 1
    Country: Number of subjects enrolled
    United States: 349
    Worldwide total number of subjects
    433
    EEA total number of subjects
    47
    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)
    339
    From 65 to 84 years
    94
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Approximately 400 participants were planned. A total of 696 Participants entered the screening run-in period, 433 enrolled in the open-label treatment period of the study at Week 0, and 350 entered the continued open-label/double-blind treatment period at Week 16.

    Period 1
    Period 1 title
    Open-label (OL) Period (Week 0 – 16)
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
    Arm description
    All Participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO 148
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    All Participants receive golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks+Methotrexate (MTX) from Week 0 to Week 12.

    Number of subjects in period 1
    Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
    Started
    433
    Completed
    350
    Not completed
    83
         Protocol deviation
    29
         Lack of efficacy
    15
         Adverse event, non-fatal
    20
         Consent withdrawn by subject
    17
         Lost to follow-up
    2
    Period 2
    Period 2 title
    OL/Double-Blind (DB) Period (Week 16-52)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    OL Group 1: Golimumab 50 mg SC + MTX
    Arm description
    Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO 148
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.

    Arm title
    Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M
    Arm description
    Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO 148
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants, who did not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.

    Arm title
    DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Arm description
    Participants, who did not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO 148
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants, who did not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.

    Number of subjects in period 2
    OL Group 1: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Started
    75
    91
    184
    Completed
    65
    54
    126
    Not completed
    10
    37
    58
         Death
    -
    -
    1
         Protocol deviation
    3
    3
    4
         Lack of efficacy
    2
    24
    37
         Adverse event, non-fatal
    1
    5
    6
         Consent withdrawn by subject
    1
    4
    7
         Lost to follow-up
    3
    1
    3
    Period 3
    Period 3 title
    OL Study Extension (Week 52 - 76)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    OL Study Extension Group: Golimumab 50 mg SC + MTX
    Arm description
    Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    CNTO 148
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.

    Number of subjects in period 3 [1]
    OL Study Extension Group: Golimumab 50 mg SC + MTX
    Started
    212
    Completed
    194
    Not completed
    18
         Protocol deviation
    4
         Lack of efficacy
    10
         Adverse event, non-fatal
    2
         Consent withdrawn by subject
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who completed the main study and did not meet lack of efficacy criteria, participated in the OL study extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label (OL) Period (Week 0 – 16)
    Reporting group description
    -

    Reporting group values
    Open-label (OL) Period (Week 0 – 16) Total
    Number of subjects
    433 433
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    339 339
        From 65 to 84 years
    94 94
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    55.7 ± 11.52 -
    Title for Gender
    Units: subjects
        Female
    358 358
        Male
    75 75

    End points

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    End points reporting groups
    Reporting group title
    Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
    Reporting group description
    All Participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
    Reporting group title
    OL Group 1: Golimumab 50 mg SC + MTX
    Reporting group description
    Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.

    Reporting group title
    Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M
    Reporting group description
    Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.

    Reporting group title
    DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Reporting group description
    Participants, who did not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
    Reporting group title
    OL Study Extension Group: Golimumab 50 mg SC + MTX
    Reporting group description
    Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.

    Subject analysis set title
    Modified Intent To Treat (mITT)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Modified Intent To Treat (mITT) Population included all enrolled participants who had Week 0 measurements and received at least 1 dose of study drug.

    Subject analysis set title
    Open-label modified Intent To Treat (mITT)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Open-label modified Intent To Treat (mITT) population included all participants, who received at least 1 open-label Golimumab 50 milligram (mg) subcutaneous (SC) injection during the continued open-label/ double-blind treatment period.

    Subject analysis set title
    Double-blind modified Intent To Treat (mITT)
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Double-blind modified Intent To Treat (mITT) population included Participants who were randomized at Week 16 to subcutaneous (SC) or IV Golimumab (Groups 2a and 2b) and received at least 1 dose of study drug after randomization.

    Primary: Percentage of Participants Achieving Erythrocyte Sedimentation Rate Based ACR 20 Response at Week 14

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    End point title
    Percentage of Participants Achieving Erythrocyte Sedimentation Rate Based ACR 20 Response at Week 14 [1]
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant's s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
    End point type
    Primary
    End point timeframe
    week 14
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis were performed for this endpoint.
    End point values
    Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
    Number of subjects analysed
    433
    Units: Percentage of Participants
        number (confidence interval 95%)
    34.9 (30.4 to 39.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Erythrocyte Sedimentation rate Based ACR20 Response at Week 2

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    End point title
    Percentage of Participants Who Achieved Erythrocyte Sedimentation rate Based ACR20 Response at Week 2
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: greater than or equal to (>=) 20 percent (%) improvement from Baseline in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Baseline in 3 of the following 5 assessments: 1- Participant’s assessment of pain using Visual Analog Scale (VAS) (0 to 10 centimeters [cm]), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR.
    End point type
    Secondary
    End point timeframe
    Within 2 weeks of initiating therapy
    End point values
    Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX
    Number of subjects analysed
    433
    Units: Percentage of Participants
        number (confidence interval 95%)
    24.5 (20.4 to 28.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate based DAS28 Response at Week 16 and Through Week 52

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    End point title
    Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate based DAS28 Response at Week 16 and Through Week 52
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) as defined by European League Against Rheumatism (EULAR), response criteria was used to assess individual response as none, moderate, or good, depending on the extent of change from Baseline and the level of disease activity reached. A participant was classified as having achieved a DAS28 good response if, DAS28 was less than or equal to (<=) 3.2 at a given visit and improvement from Baseline was >1.2. Percentage of participants, who achieved ESR-based DAS 28 good response at Week 16 and maintained that response through Week 52, was reported.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Number of subjects analysed
    91
    184
    Units: Percentage of Participants
        number (confidence interval 95%)
    13.2 (6.2 to 20.1)
    9.2 (5.1 to 13.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate - Based ACR20 Response at Week 52 Relative to Week 16

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    End point title
    Percentage of Participants Who Achieved Erythrocyte Sedimentation Rate - Based ACR20 Response at Week 52 Relative to Week 16
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) joint counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4- Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR. Percentage of participants, who achieved ESR-based ACR 20 responses at Week 52 relative to Week 16, was reported.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    Number of subjects analysed
    Units: Percentage of Participants
        number (confidence interval 95%)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP) - Based ACR20 Response at Week 76 Relative to Week 16

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    End point title
    Percentage of Participants Who Achieved ESR-based and C-Reactive Protein (CRP) - Based ACR20 Response at Week 76 Relative to Week 16
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based/ C Reactive Protein (CRP)-based ACR 20 response: >=20 % improvement from Week 16 in tender (68 joints assessed) and swollen (66 joints assessed) join counts and >=20% improvement from Week 16 in 3 of the following 5 assessments: 1- Participant’s assessment of pain using VAS (0 to 10 cm), 2- Participant’s global assessment of disease activity using VAS (0 to 10 cm), 3- Physician’s global assessment of disease activity using VAS (0 to 10 cm), 4-Participant’s assessment of physical function as measured by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) (score of 0-3 in 8 functional areas), 5- ESR or CRP. Percentage of participants, who achieved ESR/ CRP-based ACR 20 responses at Week 76 relative to Week 16, was reported.
    End point type
    Secondary
    End point timeframe
    Week 76
    End point values
    OL Group 1: Golimumab 50 mg SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Number of subjects analysed
    63
    212
    47
    102
    Units: Percentage of Participants
    number (confidence interval 95%)
        ESR-based ACR 20 Response
    7.9 (1.3 to 14.6)
    11.8 (7.5 to 16.1)
    8.5 (0.5 to 16.5)
    15.7 (8.6 to 22.7)
        CRP-based ACR 20 Response
    7.9 (1.3 to 14.6)
    12.7 (8.2 to 17.2)
    8.5 (0.5 to 16.5)
    17.6 (10.2 to 25)
    No statistical analyses for this end point

    Secondary: Change in ESR-based DAS28 Score at Week 76 Relative to Week 52

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    End point title
    Change in ESR-based DAS28 Score at Week 76 Relative to Week 52
    End point description
    Erythrocyte Sedimentation Rate (ESR)-based disease activity score for 28-joints count (DAS28) was calculated from number of swollen joint counts (SJC) and tender joint counts (TJC) using 28 joints count, ESR, and patient global assessment of disease activity (participant rated arthritis activity assessment with scores ranging 0 to 10; higher scores indicated greater disease activity). Total ESRbased DAS28 score range: 0 to 9.4, higher score=more disease activity.
    End point type
    Secondary
    End point timeframe
    Week 52, 76
    End point values
    OL Group 1: Golimumab 50 mg SC + MTX OL Study Extension Group: Golimumab 50 mg SC + MTX Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+M DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX
    Number of subjects analysed
    61
    196
    40
    95
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 52 (n = 61, 40, 95, 196)
    3.182 ± 1.1109
    3.95 ± 1.2379
    4.07 ± 0.8037
    4.394 ± 1.2389
        Change at Week 76 (n = 57, 33, 84,
    -0.136 ± 1.2095
    -0.013 ± 1.1386
    0.209 ± 1.2253
    -0.017 ± 1.0518
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 0 to Week 52
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    OL Overall Group: Golimumab 50 mg SC + MTX
    Reporting group description
    All participants receieved Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 0 – 12. Where OL is used to abbreviate Open-Label.

    Reporting group title
    DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX
    Reporting group description
    Participants who did not achieved good Disease Activity Score in 28 joints (DAS28) response at Week 16. Randomized to receive Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 – 48. Placebo IV at Weeks 16, 20, 28, 36, and 44. Where DB is used to abbreviate Double Blind.

    Reporting group title
    OL Group 1: Golimumab Open Label 50 mg + MTX
    Reporting group description
    Participants who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16. Golimumab 50 mg SC injection every 4 weeks + Methotrexate (MTX) from Week 16 – 48.

    Reporting group title
    DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX
    Reporting group description
    Participants who did not achieve Disease Activity Score in 28 joints (DAS28) good response at Week 16. Randomized to receive Golimumab 2 milligram per kilogram (mg/kg) IV at Weeks 16, 20, 28, 36 and 44 + MTX. Placebo subcutaneous (SC) every 4 weeks from Week 16 – 48.

    Reporting group title
    Study Extension OL Group: Golimumab 50 mg SC + MTX
    Reporting group description
    Participants who completed Study Extension Open label receieved Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 52-72.

    Serious adverse events
    OL Overall Group: Golimumab 50 mg SC + MTX DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX OL Group 1: Golimumab Open Label 50 mg + MTX DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX Study Extension OL Group: Golimumab 50 mg SC + MTX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 433 (4.62%)
    4 / 91 (4.40%)
    2 / 75 (2.67%)
    10 / 184 (5.43%)
    10 / 212 (4.72%)
         number of deaths (all causes)
    1
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Hypotension
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Femur fracture
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Intentional overdose
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    1 / 75 (1.33%)
    0 / 184 (0.00%)
    0 / 212 (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
    Upper limb fracture
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage III
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Bradycardia
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 433 (0.46%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Pneumothorax
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Pulmonary embolism
         subjects affected / exposed
    0 / 433 (0.00%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Carotid artery occlusion
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    3 / 184 (1.63%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Gastrointestinal disorders
    Oesophagitis haemorrhagic
         subjects affected / exposed
    0 / 433 (0.00%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Back pain
         subjects affected / exposed
    2 / 433 (0.46%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Joint effusion
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Muscular weakness
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    1 / 75 (1.33%)
    0 / 184 (0.00%)
    0 / 212 (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
    Osteoarthritis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    1 / 75 (1.33%)
    0 / 184 (0.00%)
    0 / 212 (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
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Tenosynovitis
         subjects affected / exposed
    0 / 433 (0.00%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Hypokalaemia
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Cellulitis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    2 / 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
    Gastroenteritis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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 viral
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    Hepatitis C
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    1 / 212 (0.47%)
         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
    Pneumonia
         subjects affected / exposed
    1 / 433 (0.23%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    2 / 184 (1.09%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 433 (0.00%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    1 / 184 (0.54%)
    0 / 212 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Wound infection staphylococcal
         subjects affected / exposed
    1 / 433 (0.23%)
    0 / 91 (0.00%)
    0 / 75 (0.00%)
    0 / 184 (0.00%)
    0 / 212 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    OL Overall Group: Golimumab 50 mg SC + MTX DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX OL Group 1: Golimumab Open Label 50 mg + MTX DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX Study Extension OL Group: Golimumab 50 mg SC + MTX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    123 / 433 (28.41%)
    30 / 91 (32.97%)
    21 / 75 (28.00%)
    54 / 184 (29.35%)
    61 / 212 (28.77%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 433 (5.54%)
    1 / 91 (1.10%)
    0 / 75 (0.00%)
    5 / 184 (2.72%)
    3 / 212 (1.42%)
         occurrences all number
    28
    1
    0
    8
    3
    Psychiatric disorders
    Depression
         subjects affected / exposed
    7 / 433 (1.62%)
    3 / 91 (3.30%)
    4 / 75 (5.33%)
    2 / 184 (1.09%)
    5 / 212 (2.36%)
         occurrences all number
    7
    3
    4
    2
    5
    Musculoskeletal and connective tissue disorders
    Rheumatoid arthritis
         subjects affected / exposed
    13 / 433 (3.00%)
    9 / 91 (9.89%)
    2 / 75 (2.67%)
    9 / 184 (4.89%)
    11 / 212 (5.19%)
         occurrences all number
    13
    9
    2
    11
    11
    Arthralgia
         subjects affected / exposed
    20 / 433 (4.62%)
    8 / 91 (8.79%)
    2 / 75 (2.67%)
    8 / 184 (4.35%)
    11 / 212 (5.19%)
         occurrences all number
    23
    15
    2
    13
    12
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    12 / 433 (2.77%)
    6 / 91 (6.59%)
    2 / 75 (2.67%)
    11 / 184 (5.98%)
    4 / 212 (1.89%)
         occurrences all number
    12
    7
    2
    13
    4
    Sinusitis
         subjects affected / exposed
    17 / 433 (3.93%)
    4 / 91 (4.40%)
    4 / 75 (5.33%)
    13 / 184 (7.07%)
    12 / 212 (5.66%)
         occurrences all number
    18
    4
    5
    14
    12
    Upper respiratory tract infection
         subjects affected / exposed
    29 / 433 (6.70%)
    5 / 91 (5.49%)
    7 / 75 (9.33%)
    15 / 184 (8.15%)
    13 / 212 (6.13%)
         occurrences all number
    31
    5
    7
    15
    15
    Urinary tract infection
         subjects affected / exposed
    24 / 433 (5.54%)
    2 / 91 (2.20%)
    3 / 75 (4.00%)
    11 / 184 (5.98%)
    13 / 212 (6.13%)
         occurrences all number
    26
    4
    3
    11
    16

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Jul 2009
    The overall reason for the amendment was to include the following changes:The open-label or double-blind treatment period was extended from Week 36 to Week 52. The Golimumab IV dose was changed from 4 milligram per kilogram (mg/kg) IV every 8 weeks with a loading dose to 2 mg/kg IV every 8 weeks with a loading dose. The disease flare Golimumab IV rescue treatment group was removed. The American College of Rheumatology (ACR) 50 response was replaced by a Disease Activity Score in 28 joints (DAS28) good response (as defined by European League Against Rheumatism (EULAR) criteria and calculated using ESR) requirement at Week 16 to determine whether a subject would continue open label treatment or be randomized to receive double-blind treatment. The TB inclusion criterion was also modified to allow for a chest radiograph at screening. Exclusion criteria related to drugs and investigational agents received before the first dose of study agent were modified. Instructions for reporting malfunctions or damage to the autoinjectors/prefilled pens were provided. Changes to the statistical analyses included an update to the treatment failure criteria for the primary analysis, a revision to the Cochran-Mantel-Haenszel (CMH) test to include stratification by ACR 20 criteria, an update to DAS28 response (EULAR response criteria) analyses using C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), an addition of a summary of injection-site reactions for Golimumab by severity, deletion of subgroup analyses to evaluate consistency of safety over time, and a change to the significance level of the 2-sided binomial test from 0.05 to 0.049 to adjust for 1 interim analysis.
    01 Mar 2010
    The overall reason for the amendment was to include the following changes: Stopping rules were added for participants who had continued severe disease activity [Disease Activity Score in 28 joints(DAS28) greater than (>) 5.2] or diminished treatment effectiveness beginning at the Week 20 visit. The treatment regimen of etanercept or adalimumab for inclusion of participants in the study was clarified. Inclusion criteria for TB were modified. A Data Monitoring Committee (DMC) was added to monitor safety throughout the study. Information pertaining to the use of corticosteroids, Non-steroidal anti-inflammatory drugs (NSAIDs), analgesics, prohibited biologic agents, and prohibited DMARDs/systemic immunosuppressive agents were modified. The number of study sites was increased from 120 to 150 worldwide.
    10 Aug 2010
    The overall reason for the amendment was to include the following changes: A voluntary, open-label, 24 week study extension period was added. A definition for Disease Activity Score in 28 joints (DAS28) (ESR-based) low disease activity was added. Two additional secondary analyses related to DAS28 greater than or equal to (≥) 3.2 were added and the use of CRP or ESR in the definition for DAS28 remission was clarified.
    29 Oct 2010
    The overall reason for the amendment was to include the following changes: Testing for HBV infection prior to receiving study agent was added. Evaluations for suspected Tuberculosis (TB) were clarified. Revised exclusion criteria, and other applicable protocol sections, related to treatment with disease modifying antirheumatic drugs (DMARDS)/systemic immunosuppressive agents and intra-articular, intramuscular (IM), or IV corticosteroids were changed to specify the prohibited use (in weeks or months) relative to screening instead of the administration of study agent. Gout was added to the list of excluded inflammatory diseases other than RA. Infraclavicular was changed to supraclavicular regarding location of lymph nodes in exclusion criteria for symptoms of possible lymphoproliferative disease. The description of the assessment and documentation of joints that were replaced before the study was modified to clarify that an entry in the electronic case report form (eCRF) indicating “nonevaluable” for a replaced joint would supersede the blinded value from the independent joint assessment on the joint assessment worksheet. This amendment also specified that Participants who participated in the extension would not be unblinded to their main study treatment assignment at the time of study extension entry.
    28 Jan 2011
    The overall reason for the amendment was to include the following changes: HBV testing at the next study visit for all Participants who were currently participating in the trial and to use the results to determine continued subject participation in the trial. The definition of a serious adverse event was updated to include the suspected transmission of an infectious agent by a medicinal product per the current definition in Volume 9A of The Rules Governing Medicinal Products in the European Union – Guidelines on Pharmacovigilance for Medicinal Products for Human Use (September 2008).
    12 Oct 2011
    The overall reason for the amendment was to include the following changes: to add prefilled syringes as an additional method of administering study agent to ensure that Participants would not miss an administration of study drug should autoinjector supplies become limited. The use of corticosteroids in the study was clarified. This amendment also included/corrected text describing when a subject should have been discontinued from the study in the event he/she tested positive for hepatitis B virus (HBV) during the 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.
    The presence of TNF-resistant Participants who enriched the double blind phase of the study since they had already failed to respond to at least 2 anti-TNF agents (etanercept and/or adalimumab and golimumab).
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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