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    Clinical Trial Results:
    A Phase 2A Randomized, double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2018-001510-15
    Trial protocol
    		 DE   PL  
    Global end of trial date
    15 Nov 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1959UCO2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03662542
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 Route 202 South, Raritan, United States, 08869
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, 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
    15 Nov 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Nov 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this trial was to evaluate the clinical efficacy and safety of combination therapy with guselkumab and golimumab in subjects with moderately to severely active ulcerative colitis (UC).
    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.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2018
    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
    Argentina: 4
    Country: Number of subjects enrolled
    Australia: 4
    Country: Number of subjects enrolled
    Brazil: 9
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Poland: 40
    Country: Number of subjects enrolled
    Russian Federation: 71
    Country: Number of subjects enrolled
    Ukraine: 68
    Country: Number of subjects enrolled
    United States: 12
    Worldwide total number of subjects
    214
    EEA total number of subjects
    42
    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)
    213
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 214 subjects were enrolled and received guselkumab and/or golimumab.

    Period 1
    Period 1 title
    Combination Phase (Through Week 12)
    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
    		 Arm 1: Golimumab Monotherapy
    Arm description
    		 Subjects received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg at Weeks 2, 6 and 10. Subjects received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8.
    Arm type
    		 Active comparator

    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 as intravenous (IV) infusion at Weeks 0, 4 and 8.

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg at Weeks 2, 6 and 10.

    Arm title
    		 Arm 2: Guselkumab Monotherapy
    Arm description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Subjects received placebo as SC injection at Weeks 0, 2, 6, and 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as SC injection at Weeks 0, 2, 6, and 10.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8.

    Arm title
    		 Arm 3: Combination Therapy
    Arm description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6, and 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6, and 10.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8.

    Number of subjects in period 1
    		Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy
    Started
    72
    71
    71
    Completed
    67
    70
    71
    Not completed
    5
    1
    0
         Consent withdrawn by subject
    3
    -
    -
         Adverse event, non-fatal
    -
    1
    -
         Unspecified
    2
    -
    -
    Period 2
    Period 2 title
    Monotherapy Phase (Week 12 to Week 38)
    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
    		 Arm 1: Golimumab Monotherapy
    Arm description
    		 Subjects received golimumab 100 mg at Weeks 14, 18, 22, 26, 30, and 34 and placebo as SC injection at Weeks 16, 24, and 32.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as SC injection at Weeks 16, 24, and 32.

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg at Weeks 14, 18, 22, 26, 30, and 34.

    Arm title
    		 Arm 2: Guselkumab Monotherapy
    Arm description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.

    Arm title
    		 Arm 3: Combination Therapy
    Arm description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32.

    Number of subjects in period 2
    		Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy
    Started
    67
    70
    71
    Completed
    62
    67
    65
    Not completed
    5
    3
    6
         Consent withdrawn by subject
    4
    1
    1
         Adverse event, non-fatal
    -
    -
    2
         Death
    -
    -
    1
         Unspecified
    -
    1
    2
         Lost to follow-up
    1
    1
    -
    Period 3
    Period 3 title
    Safety Follow-up Phase (Week 38- EOS)
    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
    		 Arm 1: Golimumab Monotherapy
    Arm description
    		 Subjects were followed up after Week 38 to Week 50 (end of study [EOS]) and did not receive any additional medication in the safety follow-up phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects did not receive any additional medication in the safety follow-up phase.

    Arm title
    		 Arm 2: Guselkumab Monotherapy
    Arm description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Injection
    Routes of administration
    Intravenous use, Subcutaneous use
    Dosage and administration details
    Subjects did not receive any additional medication in the safety follow-up phase.

    Arm title
    		 Arm 3: Combination Therapy
    Arm description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Guselkumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion, Injection
    Routes of administration
    Subcutaneous use, Intravenous use
    Dosage and administration details
    Subjects did not receive any additional medication in the safety follow-up phase.

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects did not receive any additional medication in the safety follow-up phase.

    Number of subjects in period 3 [1]
    		Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy
    Started
    58
    65
    60
    Completed
    55
    58
    55
    Not completed
    3
    7
    5
         Consent withdrawn by subject
    1
    -
    2
         Death
    -
    1
    -
         Unspecified
    1
    6
    2
         Lost to follow-up
    1
    -
    1
    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: Out of 194 subjects (who completed Period-2 [monotherapy phase]), 183 subjects started the Period-3 (safety follow-up phase).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg at Weeks 2, 6 and 10. Subjects received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8.

    Reporting group title
    Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Subjects received placebo as SC injection at Weeks 0, 2, 6, and 10.

    Reporting group title
    Arm 3: Combination Therapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6, and 10.

    Reporting group values
    		 Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy Total
    Number of subjects
    		 72 71 71 214
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 72 70 71 213
        From 65 to 84 years
    		 0 1 0 1
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 10.47 ) 39.1 ( 13.67 ) 37.8 ( 11.69 ) -
    Title for Gender
    Units: subjects
        Female
    		 30 31 37 98
        Male
    		 42 40 34 116

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg at Weeks 2, 6 and 10. Subjects received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8.

    Reporting group title
    Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4 and 8. Subjects received placebo as SC injection at Weeks 0, 2, 6, and 10.

    Reporting group title
    Arm 3: Combination Therapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6, and 10.
    Reporting group title
    Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects received golimumab 100 mg at Weeks 14, 18, 22, 26, 30, and 34 and placebo as SC injection at Weeks 16, 24, and 32.

    Reporting group title
    Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.

    Reporting group title
    Arm 3: Combination Therapy
    Reporting group description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.
    Reporting group title
    Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (end of study [EOS]) and did not receive any additional medication in the safety follow-up phase.

    Reporting group title
    Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.

    Reporting group title
    Arm 3: Combination Therapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.

    Primary: Percentage of Subjects Who Achieved Clinical Response at Week 12

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    End point title
    		 Percentage of Subjects Who Achieved Clinical Response at Week 12 [1]
    End point description
    Clinical response is defined as a decrease from baseline in the Mayo score greater than or equal to (>=) 30 percent (%) and >=3 points with either a decrease from baseline in the rectal bleeding subscore (RBS) >=1 or a RBS of 0 or 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings - each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Efficacy analyses were based on the Full Analysis Set (FAS), which included all randomised subjects who received at least 1 (partial or complete) dose of study intervention.
    End point type
    Primary
    End point timeframe
    Week 12
    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 inferential statistics was done. Only descriptive statistics was performed.
    End point values
    		 Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy
    Number of subjects analysed
    72
    71
    71
    Units: Percentage of subjects
        number (not applicable)
    61.1
    74.6
    83.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Clinical Remission at Week 12

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    End point title
    		 Percentage of Subjects Who Achieved Clinical Remission at Week 12
    End point description
    Clinical remission (legacy definition) is defined as the Mayo score less than or equal to (<=) 2 with no individual subscore greater than (>) 1. The Mayo score was calculated as the sum of 4 subscores (stool frequency, rectal bleeding, physician's global assessment, and endoscopy findings) each with score range of 0 (normal activity) to 3 (severe activity) and a total score range of 0 to 12 points. A score of 3 to 5 points indicates mildly active disease, a score of 6 to 10 points indicates moderately active disease, and a score of 11 to 12 points indicates severely active disease. Efficacy analyses were based on the FAS, which included all randomised subjects who received at least 1 (partial or complete) dose of study intervention.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Arm 1: Golimumab Monotherapy Arm 2: Guselkumab Monotherapy Arm 3: Combination Therapy
    Number of subjects analysed
    72
    71
    71
    Units: Percentage of subjects
        number (not applicable)
    22.2
    21.1
    36.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 50
    Adverse event reporting additional description
    The safety analysis set included all randomised subjects who received at least 1 (partial or complete) dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Combination Phase: Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects received golimumab 200 milligrams (mg) as subcutaneous (SC) injection at Week 0, followed by golimumab 100 mg at Weeks 2, 6 and 10. Subjects received placebo as intravenous (IV) infusion at Weeks 0, 4 and 8.

    Reporting group title
    Safety Follow-up Phase: Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.

    Reporting group title
    Safety Follow-up Phase: Arm 3: Combination Therapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (EOS) and did not receive any additional medication in the safety follow-up phase.

    Reporting group title
    Monotherapy Phase: Arm 3: Combination Therapy
    Reporting group description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24 and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.

    Reporting group title
    Combination Phase: Arm 3: Combination Therapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Weeks 0, 4, and 8. Subjects received golimumab 200 mg as SC injection at Week 0, followed by golimumab 100 mg as SC injection at Weeks 2, 6, and 10.

    Reporting group title
    Monotherapy Phase: Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects received golimumab 100 mg at Week 14, 18, 22, 26, 30, and 34 and placebo as SC injection at Weeks 16, 24, and 32.

    Reporting group title
    Monotherapy Phase: Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects received guselkumab 100 mg as SC injection at Weeks 16, 24, and 32 and placebo as SC injection at Weeks 14, 18, 22, 26, 30, and 34.

    Reporting group title
    Safety Follow-up Phase: Arm 1: Golimumab Monotherapy
    Reporting group description
    		 Subjects were followed up after Week 38 to Week 50 (end of study [EOS]) and did not receive any additional medication in the safety follow-up phase.

    Reporting group title
    Combination Phase: Arm 2: Guselkumab Monotherapy
    Reporting group description
    		 Subjects received guselkumab 200 mg as IV infusion at Week 0, 4 and 8. Subjects received placebo as SC injection at Weeks 0, 2, 6, and 10.

    Serious adverse events
    		 Combination Phase: Arm 1: Golimumab Monotherapy Safety Follow-up Phase: Arm 2: Guselkumab Monotherapy Safety Follow-up Phase: Arm 3: Combination Therapy Monotherapy Phase: Arm 3: Combination Therapy Combination Phase: Arm 3: Combination Therapy Monotherapy Phase: Arm 1: Golimumab Monotherapy Monotherapy Phase: Arm 2: Guselkumab Monotherapy Safety Follow-up Phase: Arm 1: Golimumab Monotherapy Combination Phase: Arm 2: Guselkumab Monotherapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 72 (1.39%)
    2 / 65 (3.08%)
    0 / 60 (0.00%)
    3 / 71 (4.23%)
    1 / 71 (1.41%)
    3 / 67 (4.48%)
    1 / 70 (1.43%)
    0 / 58 (0.00%)
    2 / 71 (2.82%)
         number of deaths (all causes)
    0
    1
    0
    1
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of Colon
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 65 (1.54%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Poisoning
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    1 / 72 (1.39%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 65 (1.54%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    1 / 67 (1.49%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    1 / 70 (1.43%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 67 (1.49%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 72 (0.00%)
    1 / 65 (1.54%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19 Pneumonia
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 67 (1.49%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis of Intrathoracic Lymph Nodes
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 72 (0.00%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    1 / 71 (1.41%)
    0 / 71 (0.00%)
    0 / 67 (0.00%)
    0 / 70 (0.00%)
    0 / 58 (0.00%)
    0 / 71 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Combination Phase: Arm 1: Golimumab Monotherapy Safety Follow-up Phase: Arm 2: Guselkumab Monotherapy Safety Follow-up Phase: Arm 3: Combination Therapy Monotherapy Phase: Arm 3: Combination Therapy Combination Phase: Arm 3: Combination Therapy Monotherapy Phase: Arm 1: Golimumab Monotherapy Monotherapy Phase: Arm 2: Guselkumab Monotherapy Safety Follow-up Phase: Arm 1: Golimumab Monotherapy Combination Phase: Arm 2: Guselkumab Monotherapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 72 (26.39%)
    2 / 65 (3.08%)
    0 / 60 (0.00%)
    14 / 71 (19.72%)
    14 / 71 (19.72%)
    12 / 67 (17.91%)
    16 / 70 (22.86%)
    3 / 58 (5.17%)
    16 / 71 (22.54%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    3 / 71 (4.23%)
    4 / 71 (5.63%)
    2 / 67 (2.99%)
    5 / 70 (7.14%)
    0 / 58 (0.00%)
    3 / 71 (4.23%)
         occurrences all number
    2
    0
    0
    6
    8
    4
    9
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 72 (6.94%)
    1 / 65 (1.54%)
    0 / 60 (0.00%)
    0 / 71 (0.00%)
    4 / 71 (5.63%)
    2 / 67 (2.99%)
    6 / 70 (8.57%)
    0 / 58 (0.00%)
    6 / 71 (8.45%)
         occurrences all number
    5
    1
    0
    0
    5
    2
    7
    0
    7
    Neutropenia
         subjects affected / exposed
    2 / 72 (2.78%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    2 / 71 (2.82%)
    2 / 71 (2.82%)
    1 / 67 (1.49%)
    2 / 70 (2.86%)
    0 / 58 (0.00%)
    4 / 71 (5.63%)
         occurrences all number
    2
    0
    0
    3
    4
    1
    2
    0
    4
    Gastrointestinal disorders
    Colitis Ulcerative
         subjects affected / exposed
    8 / 72 (11.11%)
    1 / 65 (1.54%)
    0 / 60 (0.00%)
    6 / 71 (8.45%)
    4 / 71 (5.63%)
    5 / 67 (7.46%)
    4 / 70 (5.71%)
    3 / 58 (5.17%)
    1 / 71 (1.41%)
         occurrences all number
    8
    1
    0
    6
    4
    5
    5
    3
    1
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 72 (5.56%)
    0 / 65 (0.00%)
    0 / 60 (0.00%)
    6 / 71 (8.45%)
    1 / 71 (1.41%)
    2 / 67 (2.99%)
    2 / 70 (2.86%)
    0 / 58 (0.00%)
    5 / 71 (7.04%)
         occurrences all number
    5
    0
    0
    6
    1
    2
    4
    0
    5

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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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