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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 Ankylosing Spondylitis

    Summary
    EudraCT number
    		 2014-000241-74
    Trial protocol
    		 DE  
    Global end of trial date
    14 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Oct 2017
    First version publication date
    27 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CNTO148AKS3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02186873
    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
    11 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Oct 2016
    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 intravenous (IV) administration of golimumab 2 milligram per kilogram (mg/kg) in subjects with active ankylosing spondylitis (AS) by assessing the reduction in signs and symptoms of AS.
    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 AEs, physical examinations, electrocardiograms (screening only), concomitant medications, infusion reaction evaluations, and assessments of allergic reactions. Tuberculosis (TB) evaluations were performed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 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
    Canada: 2
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 18
    Country: Number of subjects enrolled
    Mexico: 6
    Country: Number of subjects enrolled
    Poland: 68
    Country: Number of subjects enrolled
    Russian Federation: 30
    Country: Number of subjects enrolled
    Ukraine: 59
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    208
    EEA total number of subjects
    76
    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)
    207
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 312 subjects screened, 208 subjects were randomized (105 to golimumab 2 milligram per kilogram [mg/kg] and 103 to placebo group) and treated.

    Period 1
    Period 1 title
    Overall Period
    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
    		 Group 1: Placebo then Golimumab
    Arm description
    		 Subjects received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 subjects were crossed over to golimumab and received IV golimumab 2 milligram per kilogram (mg/kg) infusion at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.
    Arm type
    		 Experimental

    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 placebo intravenous infusions at Weeks 0, 4, and 12.

    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 received golimumab 2 mg/kg infusion at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.

    Arm title
    		 Group 2: Golimumab
    Arm description
    		 Subjects received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Subjects received a placebo infusion at Week 16 to maintain the treatment blind.
    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 received intravenous golimumab 2 mg/kg infusion at Weeks 0, 4 and q8w thereafter through Week 52.

    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 placebo intravenous (IV) infusions at Week 16.

    Number of subjects in period 1
    		Group 1: Placebo then Golimumab Group 2: Golimumab
    Started
    103
    105
    End of Control Period
    99
    105
    Completed
    94
    97
    Not completed
    9
    8
         Consent withdrawn by subject
    7
    2
         Adverse event, non-fatal
    1
    3
         Lost to follow-up
    1
    2
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1: Placebo then Golimumab
    Reporting group description
    		 Subjects received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 subjects were crossed over to golimumab and received IV golimumab 2 milligram per kilogram (mg/kg) infusion at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.

    Reporting group title
    Group 2: Golimumab
    Reporting group description
    		 Subjects received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Subjects received a placebo infusion at Week 16 to maintain the treatment blind.

    Reporting group values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab Total
    Number of subjects
    		 103 105 208
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 102 105 207
        From 65 to 84 years
    		 1 0 1
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.2 ± 10.75 38.4 ± 10.11 -
    Title for Gender
    Units: subjects
        Female
    		 26 19 45
        Male
    		 77 86 163

    End points

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    End points reporting groups
    Reporting group title
    Group 1: Placebo then Golimumab
    Reporting group description
    		 Subjects received placebo intravenous (IV) infusions at Weeks 0, 4, and 12. At Week 16 subjects were crossed over to golimumab and received IV golimumab 2 milligram per kilogram (mg/kg) infusion at Weeks 16, 20, and every 8 weeks (q8w) thereafter through Week 52.

    Reporting group title
    Group 2: Golimumab
    Reporting group description
    		 Subjects received IV golimumab 2 mg/kg infusion at Weeks 0, 4 and then q8w thereafter through Week 52. Subjects received a placebo infusion at Week 16 to maintain the treatment blind.

    Primary: Percentage of Subjects Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 20 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 20) at Week 16
    End point description
    ASAS 20 defined as 20 percent (%) improvement compared to baseline in the ASAS Working Group criteria: that is, greater than or equal to (>=)20% improvement from baseline in at least 3 of the 4 domains: patient’s global assessment of disease activity (0=very well,10 =very poor), total back pain (0=no pain,10=most severe pain), function (self-assessment using BASFI [0=no functional impairment to 10= maximal impairment]), inflammation (0=none,10=very severe) with an absolute improvement of at least 1 (0-10 centimeter (cm) visual analogue scale [VAS]), and an absence of deterioration (defined as >=20% worsening and absolute worsening of at least 1 on a 0-10 cm scale) in the potential remaining domain. Full Analysis Set (FAS) included all subjects who were randomized in the study.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    103
    105
    Units: Percentage of Subjects
        number (not applicable)
    26.2
    73.3
    Statistical analysis title
    		 Statistics Analysis 1
    Comparison groups
    Group 2: Golimumab v Group 1: Placebo then Golimumab
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Percent Difference
    Point estimate
    47.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 35.18
         upper limit
    		 58.99

    Secondary: Percentage of Subjects Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 40 Percent Improvement From Baseline in the Assessment of SpondyloArthritis International Society (ASAS 40) at Week 16
    End point description
    An ASAS 40 response is defined as >=40% improvement from baseline in 3 of 4 domains: patient's global assessment of disease activity (0=very well, 10=very poor), total back pain (0=no pain, 10=most severe pain), function (self-assessment using BASFI (0=no functional impairment to 10=maximal impairment), inflammation (0=none, 10=very severe) with an absolute improvement of at least 2 (0-10 cm VAS), and no deterioration in the remaining domain. FAS included all subjects who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    103
    105
    Units: Percentage of Subjects
        number (not applicable)
    8.7
    47.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16

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    End point title
    		 Percentage of Subjects Who Achieved at Least 50 Percent Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 16
    End point description
    The BASDAI is a self-assessment tool to determine disease activity using a VAS of 0-10 cm (0=none and 10=very severe) subject's answered 6 questions measuring fatigue, spinal pain, joint pain, enthesitis, and morning stiffness. The final BASDAI is calculated as a mean of individual questions with a final score range of 0 to 10 cm; 0=best and 10=worst. FAS included all subjects who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    103
    105
    Units: Percentage of Subjects
        number (not applicable)
    14.6
    41.0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16

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    End point title
    		 Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score at Week 16
    End point description
    The BASFI is a subject's self-assessment of physical function represented as a mean of 10 questions, each question rated on VAS 0 to 10 cm (VAS 0 to 10 cm; 0=easy to 10=impossible), 8 of which relate to the subject's functional anatomy and 2 of which relate to a participant's ability to cope with everyday life. 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 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    98
    105
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    -0.471 ± 1.9558
    -2.386 ± 2.1300
    No statistical analyses for this end point

    Secondary: Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16

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    End point title
    		 Change From Baseline in Short Form-36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
    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 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    98
    104
    Units: Units on Scale
        arithmetic mean (standard deviation)
    2.86 ± 6.177
    8.52 ± 7.535
    No statistical analyses for this end point

    Secondary: Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16

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    End point title
    		 Change From Baseline in Short Form-36 Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 16
    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 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    98
    104
    Units: Units on Scale
        arithmetic mean (standard deviation)
    0.78 ± 10.004
    6.47 ± 9.122
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Low Level of Disease Activity (ASAS Partial Remission) at Week 16

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    End point title
    		 Percentage of Subjects With Low Level of Disease Activity (ASAS Partial Remission) at Week 16
    End point description
    Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient’s global assessment of disease activity, total back pain, function (BASFI), inflammation. FAS included all subjects who were randomized in the study.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    103
    105
    Units: Percentage of Subjects
        number (not applicable)
    3.9
    16.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16

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    End point title
    		 Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 16
    End point description
    The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of “yes” on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. 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 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    98
    104
    Units: Units on Scale
        arithmetic mean (standard deviation)
    -1.8 ± 4.57
    -5.4 ± 5.01
    No statistical analyses for this end point

    Secondary: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16

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    End point title
    		 Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16
    End point description
    The BASMI is an accurate and reproducible metrology index developed to assess the clinical changes in spinal movements of ankylosing spondylitis (AS) subjects. This index consists of 5 clinical measurements, including lumber side flexion, tragus to wall, lumbar flexion (modified Schober's), intermalleoar distance and cervical rotation. A BASMI response is represented as an aggregate score of 5 components (ranging from 0 [least impairment] to 10 [most impairment]). 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 16
    End point values
    		 Group 1: Placebo then Golimumab Group 2: Golimumab
    Number of subjects analysed
    96
    100
    Units: Units on Scale
        arithmetic mean (standard deviation)
    -0.10 ± 0.539
    -0.38 ± 0.625
    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
    Adverse event reporting additional description
    Safety Analysis set included all subjects who received at least 1 dose of study drug. Subjects who received placebo and crossed over to golimumab were included in placebo then golimumab 2 mg/kg arm and who received at least 1 dose of golimumab were included in placebo then golimumab 2 mg/kg and golimumab 2 mg/kg arms for safety analysis.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects who received placebo only (at least 1 dose) through Week 16. Follow-up was based on the period the subject was receiving placebo (from Week 0) up to the first golimumab 2 mg/kg dose for this treatment group.

    Reporting group title
    Placebo then Golimumab 2 mg/kg
    Reporting group description
    		 Subjects who received placebo were crossed over to golimumab 2 mg/kg at Week 16. Subjects may have also inadvertently received golimumab 2 mg/kg prior to Week 16. Subjects may have missed one or more golimumab doses. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group. Subjects who inadvertently received golimumab 2 mg/kg prior to Week 16 were applicable to include in this group.

    Reporting group title
    Golimumab 2 mg/kg
    Reporting group description
    		 Subjects who received at least one dose of 2 mg/kg golimumab from Week 0 onward. Follow-up started from the first golimumab 2 mg/kg dose for this treatment group.

    Serious adverse events
    		 Placebo Placebo then Golimumab 2 mg/kg Golimumab 2 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    6 / 105 (5.71%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 99 (1.01%)
    0 / 105 (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
    Sinus tachycardia
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         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
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 103 (0.00%)
    0 / 99 (0.00%)
    1 / 105 (0.95%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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 Placebo then Golimumab 2 mg/kg Golimumab 2 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 103 (2.91%)
    16 / 99 (16.16%)
    32 / 105 (30.48%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 103 (0.00%)
    5 / 99 (5.05%)
    7 / 105 (6.67%)
         occurrences all number
    0
    5
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 99 (1.01%)
    6 / 105 (5.71%)
         occurrences all number
    1
    1
    10
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 103 (0.97%)
    7 / 99 (7.07%)
    17 / 105 (16.19%)
         occurrences all number
    1
    7
    19
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 103 (0.97%)
    3 / 99 (3.03%)
    12 / 105 (11.43%)
         occurrences all number
    1
    3
    14

    More information

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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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