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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2014-000242-30
    Trial protocol
    		 DE   LT   ES   HU  
    Global end of trial date
    22 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Apr 2018
    First version publication date
    07 Apr 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO148PSA3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02181673
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Biologics, BV
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333CM
    Public contact
    Clinical Registry Group, Janssen Biologics, BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Biologics, BV, 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
    22 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy of intravenous (IV) administration of golimumab 2 milligram per kilogram (mg/kg) in subjects with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
    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. Safety evaluations included measurement of vital signs, assessment of adverse events (AEs), physical examinations, electrocardiogram (screening only), concomitant medications, infusion reaction evaluations, and assessments of allergic reactions and infections. Tuberculosis (TB) was also performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2014
    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
    Belarus: 22
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    Hungary: 22
    Country: Number of subjects enrolled
    Lithuania: 30
    Country: Number of subjects enrolled
    Poland: 77
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Russian Federation: 153
    Country: Number of subjects enrolled
    Ukraine: 147
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    480
    EEA total number of subjects
    140
    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)
    446
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 817 subjects were screened and 480 subjects were randomized to treatment (241 to golimumab 2 milligram per kilogram [mg/kg] and 239 to placebo).

    Period 1
    Period 1 title
    Up to Week 24
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo (week 0-24)
    Arm description
    		 Subjects received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.

    Arm title
    		 Golimumab 2 mg/kg (Week 0-60)
    Arm description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo IV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a placebo intravenous infusion at week 24 to maintain the blind.

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52.

    Number of subjects in period 1
    		Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Started
    239
    241
    Treated
    239
    240
    Completed
    222
    230
    Not completed
    17
    11
         Consent withdrawn by subject
    10
    1
         Physician decision
    -
    3
         Adverse event, non-fatal
    2
    3
         Death
    1
    -
         Unspecified
    2
    3
         Lost to follow-up
    1
    -
         Randomized not Treated
    -
    1
         Lack of efficacy
    1
    -
    Period 2
    Period 2 title
    Week 24-Week 60
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo then Golimumab 2 mg/kg (Week 24-60)
    Arm description
    		 Subjects who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.

    Arm title
    		 Golimumab 2 mg/kg (Week 0-60)
    Arm description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab 2 mg/kg (Week 0-60)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.

    Number of subjects in period 2
    		Placebo then Golimumab 2 mg/kg (Week 24-60) Golimumab 2 mg/kg (Week 0-60)
    Started
    222
    230
    Treated
    220
    230
    Completed
    214
    213
    Not completed
    8
    17
         Consent withdrawn by subject
    2
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    4
    10
         Pregnancy
    -
    1
         Unspecified
    2
    1
         Lost to follow-up
    -
    1
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo (week 0-24)
    Reporting group description
    		 Subjects received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.

    Reporting group title
    Golimumab 2 mg/kg (Week 0-60)
    Reporting group description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.

    Reporting group values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60) Total
    Number of subjects
    		 239 241 480
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 218 228 446
        From 65 to 84 years
    		 21 13 34
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.7 ± 12.53 45.7 ± 11.25 -
    Title for Gender
    Units: subjects
        Female
    		 118 113 231
        Male
    		 121 128 249

    End points

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    End points reporting groups
    Reporting group title
    Placebo (week 0-24)
    Reporting group description
    		 Subjects received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.

    Reporting group title
    Golimumab 2 mg/kg (Week 0-60)
    Reporting group description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.
    Reporting group title
    Placebo then Golimumab 2 mg/kg (Week 24-60)
    Reporting group description
    		 Subjects who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.

    Reporting group title
    Golimumab 2 mg/kg (Week 0-60)
    Reporting group description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.

    Primary: Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14

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    End point title
    		 Percentage of Subjects who Achieved an American College of Rheumatology (ACR) 20 Response at Week 14
    End point description
    The ACR 20 response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP). The full analysis set (FAS) included all subjects who were randomized.
    End point type
    Primary
    End point timeframe
    Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    239
    241
    Units: Percentage of subjects
        number (not applicable)
    21.8
    75.1
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Placebo (week 0-24) v Golimumab 2 mg/kg (Week 0-60)
    Number of subjects included in analysis
    480
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Percent Difference
    Point estimate
    53.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 45.8
         upper limit
    		 60.9

    Secondary: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14

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    End point title
    		 Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 14
    End point description
    The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). 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. The FAS included all subjects who were randomized. Here "N" (number of subjects analyzed) signifies the number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    222
    233
    Units: Units on a scale
        median (standard deviation)
    -0.12 ± 0.466
    -0.60 ± 0.530
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved an ACR 50 Response at Week 14

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    End point title
    		 Percentage of Subjects who Achieved an ACR 50 Response at Week 14
    End point description
    The ACR 50 response is defined as: greater than or equal to (>=) 50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 cm scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP). The FAS included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    239
    241
    Units: Percentage of subjects
        number (not applicable)
    6.3
    43.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14

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    End point title
    		 Percentage of Subjects who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 14
    End point description
    The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents subjects who achieved at least a 75 % improvement from baseline in the PASI score. The analysis set included randomized subjects with >= 3 % body surface area (BSA) psoriasis skin involvement at baseline. The FAS included all subjects who were randomized. Here "N" (number of subjects analyzed) signifies the number of subjects who were evaluable for this outcome measure
    End point type
    Secondary
    End point timeframe
    Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    198
    196
    Units: Percentage of subjects
        number (not applicable)
    13.6
    59.2
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24

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    End point title
    		 Change from Baseline in Total Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
    End point description
    The modified vdH-S score is a radiographic evaluation of hand and feet erosions and joint space narrowing (JSN) for 20 joints per hand and 6 joints per foot with a total score ranging from 0 (best) to 528 (worst = worst possible erosion score of 320 + worst possible JSN score of 208). Higher score and positive score changes indicate more radiographic damage and radiographic progression, respectively. FAS for structural damage endpoints (FAS-SD) defined as subjects who were randomized and treated and had a non-missing baseline total modified vdH-S score for the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    237
    237
    Units: Units on scale
        arithmetic mean (standard error)
    1.95 ± 0.264
    -0.36 ± 0.144
    No statistical analyses for this end point

    Secondary: Change from Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Subjecs With Enthesitis at Baseline

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    End point title
    		 Change from Baseline in Leeds Enthesitis Index (LEI) at Week 14 in Subjecs With Enthesitis at Baseline
    End point description
    Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in subjects with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Population included all randomized subjects with Enthesitis at Baseline. Here "N" (number of subjects analyzed) signifies the number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    173
    182
    Units: Units on scale
        arithmetic mean (standard deviation)
    -0.8 ± 1.98
    -1.8 ± 1.75
    No statistical analyses for this end point

    Secondary: Change from Baseline in Dactylitis Scores at Week 14 in Subjects With Dactylitis at Baseline

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    End point title
    		 Change from Baseline in Dactylitis Scores at Week 14 in Subjects With Dactylitis at Baseline
    End point description
    Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a subject is 0-60. Higher score indicates greater degree of tenderness. Population included all Randomized subjectss With Dactylitis (Score >0) at Baseline. Here "N" (number of subjects analyzed) signifies the number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    115
    130
    Units: Units on scale
        arithmetic mean (standard deviation)
    -2.8 ± 7.03
    -7.8 ± 8.57
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14

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    End point title
    		 Change from Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) at Week 14
    End point description
    The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score (vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. FAS included all subjects who were randomized in the study. Here, 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    222
    233
    Units: Units on scale
        arithmetic mean (standard deviation)
    2.69 ± 5.920
    8.65 ± 7.602
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24

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    End point title
    		 Percentage of Subjects Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24
    End point description
    The ACR 50 response is defined as >= 50 % improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=50% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP). The FAS included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    239
    241
    Units: Percentage of subjects
        number (not applicable)
    6.3
    53.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14

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    End point title
    		 Percentage of Subjects Who Achieved an American College of Rheumatology (ACR) 70 Response at Week 14
    End point description
    The ACR 70 response is defined as >= 70 % improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=70% improvement from baseline in at least 3 of the following 5 assessments: Patient's assessment of pain (on a 0 to 10 centimeter [cm] scale), Patient's Global Assessment of Disease Activity (on a 0 to 10 cm scale), Physician's Global Assessment of Disease Activity (on a 0 to 10 cm scale),Patient's assessment of physical function as measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI) and measurement of a blood test called C-reactive protein (CRP). The FAS included all subjects who were randomized.
    End point type
    Secondary
    End point timeframe
    Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    239
    241
    Units: Percentage of subjects
        number (not applicable)
    2.1
    24.5
    No statistical analyses for this end point

    Secondary: Change from Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14

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    End point title
    		 Change from Baseline in Short Form-36 Health Survey (SF)-36 Mental Component Summary (MCS) at Week 14
    End point description
    The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. FAS included all subjects who were randomized in the study. Here, 'N' (number of subjects analyzed) signifies number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 14
    End point values
    		 Placebo (week 0-24) Golimumab 2 mg/kg (Week 0-60)
    Number of subjects analysed
    222
    233
    Units: Units on a scale
        arithmetic mean (standard deviation)
    0.97 ± 7.644
    5.33 ± 9.948
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 60 Weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo (Week 0-24)
    Reporting group description
    		 Subjects received intravenous infusions of placebo at Weeks 0, 4, 12 and 20.

    Reporting group title
    Golimumab 2 mg/kg (Week 0-60)
    Reporting group description
    		 Subjects were randomized to receive intravenous infusions of golimumab 2 mg/kg at Weeks 0, 4 and every 8 weeks thereafter up to Week 52. At Week 24, subjects received a placebo intravenous infusion to maintain the blind.

    Reporting group title
    Placebo Then Golimumab 2 mg/kg (Week 24-60)
    Reporting group description
    		 Subjects who received placebo up to Week 20 were then crossed over at Week 24 to receive intravenous infusions of golimumab 2 milligram per kilogram (mg/kg) at Week 24, 28 and every 8 weeks thereafter up to Week 52.

    Serious adverse events
    		 Placebo (Week 0-24) Golimumab 2 mg/kg (Week 0-60) Placebo Then Golimumab 2 mg/kg (Week 24-60)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 239 (3.35%)
    19 / 240 (7.92%)
    5 / 220 (2.27%)
         number of deaths (all causes)
    2
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pleomorphic adenoma
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia aspiration
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Gene mutation identification test positive
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laboratory test abnormal
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 239 (0.42%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Epidural haemorrhage
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 239 (0.42%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac failure acute
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haematoma
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Oedematous pancreatitis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-induced liver injury
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hepatitis chronic active
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Pustular psoriasis
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urinary
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 239 (0.42%)
    0 / 240 (0.00%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Empyema
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 239 (0.42%)
    2 / 240 (0.83%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 239 (0.00%)
    2 / 240 (0.83%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 239 (0.00%)
    1 / 240 (0.42%)
    0 / 220 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 239 (0.00%)
    0 / 240 (0.00%)
    1 / 220 (0.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo (Week 0-24) Golimumab 2 mg/kg (Week 0-60) Placebo Then Golimumab 2 mg/kg (Week 24-60)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 239 (7.95%)
    40 / 240 (16.67%)
    25 / 220 (11.36%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    5 / 239 (2.09%)
    25 / 240 (10.42%)
    13 / 220 (5.91%)
         occurrences all number
    5
    31
    13
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 239 (2.09%)
    19 / 240 (7.92%)
    12 / 220 (5.45%)
         occurrences all number
    5
    24
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    13 / 239 (5.44%)
    14 / 240 (5.83%)
    9 / 220 (4.09%)
         occurrences all number
    14
    16
    10

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    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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