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    Clinical Trial Results:
    A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2012-004366-18
    Trial protocol
    		 AT   BE   DE   NL   DK   FR  
    Global end of trial date
    01 Sep 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 May 2023
    First version publication date
    07 May 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO148UCO1001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01900574
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Biologics BV
    Sponsor organisation address
    Einsteinweg 101, CB Leiden, Netherlands, 2333
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000265-PIP02-11
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2022
    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 pharmacokinetics (PK) of golimumab in pediatric subjects (aged 2 to 17 years) 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 (GCPs) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    35
    EEA total number of subjects
    11
    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)
    10
    Adolescents (12-17 years)
    25
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 56 subjects were screened at 24 sites. Of these, 35 pediatric subjects were enrolled.

    Period 1
    Period 1 title
    Main Part (14 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Golimumab
    Arm description
    		 Subjects with moderately to severely active ulcerative colitis (UC), received subcutaneous (SC) golimumab based on body weight in main part of study that is (i.e.) body weight less than (<) 45 kilogram (kg) received 90 milligrams per meter squared (mg/m^2) (up to maximum of 200 milligrams [mg]) at Week 0 and 45 mg/m^2 (up to maximum of 100 mg) at Week 2. Subjects with body weight greater than or equal to (>=) 45 kg received 200 mg at Week 0 and 100 mg at Week 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    SIMPONI
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC golimumab injection based on body weight at Weeks 0 and 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10.

    Number of subjects in period 1
    		Golimumab
    Started
    35
    Completed
    31
    Not completed
    4
         Consent withdrawn by subject
    2
         Unspecified
    1
         Lost to follow-up
    1
    Period 2
    Period 2 title
    Extension Part (112 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Golimumab
    Arm description
    		 Subjects with clinical response at Week 6 entered study extension part at Week 14 and received maintenance therapy of golimumab 100 mg (body weight >=45 kg) or 45 mg/m^2 (body weight <45 kg) every 4 weeks (q4w) through Week 110. Subjects who did not continue to receive golimumab after Week 110, returned for a final visit at Week 126. At Week 114, subjects who, in the opinion of the investigator, were benefited from continued treatment, received golimumab through Week 126 in extension part and then continued the treatment with Golimumab in long term extension part.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    SIMPONI
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC golimumab injection every 4 weeks based on body weight from Week 14 through Week 126.

    Number of subjects in period 2 [1]
    		Golimumab
    Started
    20
    Completed
    18
    Not completed
    2
         Unspecified
    2
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Only eligible subjects entered into Extension Part.
    Period 3
    Period 3 title
    Long Term Extension Part (308 weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Golimumab
    Arm description
    		 At Week 114, subjects who, in the opinion of the investigator, were benefited from continued treatment, received similar golimumab dose through Week 126 in extension part and then continued the treatment with Golimumab, every 4 weeks from Week 126 through Week 434 in long term extension part.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Golimumab
    Investigational medicinal product code
    Other name
    SIMPONI
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received SC golimumab injection every 4 weeks from Week 126 through Week 434.

    Number of subjects in period 3 [2]
    		Golimumab
    Started
    11
    Completed
    11
    Notes
    [2] - 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: Only eligible subjects entered into Extension Part.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects with moderately to severely active ulcerative colitis (UC), received subcutaneous (SC) golimumab based on body weight in main part of study that is (i.e.) body weight less than (<) 45 kilogram (kg) received 90 milligrams per meter squared (mg/m^2) (up to maximum of 200 milligrams [mg]) at Week 0 and 45 mg/m^2 (up to maximum of 100 mg) at Week 2. Subjects with body weight greater than or equal to (>=) 45 kg received 200 mg at Week 0 and 100 mg at Week 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10.

    Reporting group values
    		 Golimumab Total
    Number of subjects
    		 35 35
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 10 10
        Adolescents (12-17 years)
    		 25 25
        Adults (18-64 years)
    		 0 0
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 13.4 ( 3.21 ) -
    Title for Gender
    Units: subjects
        Female
    		 18 18
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects with moderately to severely active ulcerative colitis (UC), received subcutaneous (SC) golimumab based on body weight in main part of study that is (i.e.) body weight less than (<) 45 kilogram (kg) received 90 milligrams per meter squared (mg/m^2) (up to maximum of 200 milligrams [mg]) at Week 0 and 45 mg/m^2 (up to maximum of 100 mg) at Week 2. Subjects with body weight greater than or equal to (>=) 45 kg received 200 mg at Week 0 and 100 mg at Week 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10.
    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects with clinical response at Week 6 entered study extension part at Week 14 and received maintenance therapy of golimumab 100 mg (body weight >=45 kg) or 45 mg/m^2 (body weight <45 kg) every 4 weeks (q4w) through Week 110. Subjects who did not continue to receive golimumab after Week 110, returned for a final visit at Week 126. At Week 114, subjects who, in the opinion of the investigator, were benefited from continued treatment, received golimumab through Week 126 in extension part and then continued the treatment with Golimumab in long term extension part.
    Reporting group title
    Golimumab
    Reporting group description
    		 At Week 114, subjects who, in the opinion of the investigator, were benefited from continued treatment, received similar golimumab dose through Week 126 in extension part and then continued the treatment with Golimumab, every 4 weeks from Week 126 through Week 434 in long term extension part.

    Subject analysis set title
    Golimumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects with moderately to severely active UC, received SC golimumab based on body weight in main part of study that is (i.e.) body <45 kg received 90 mg/m^2 (up to maximum of 200 mg) at Week 0 and 45 mg/m^2 (up to maximum of 100 mg) at Week 2. Subjects with body weight >=45 kg received 200 mg at Week 0 and 100 mg at Week 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10. Subjects with clinical response at Week 6 entered study extension part at Week 14 and received maintenance therapy of golimumab 100 mg (body weight >=45 kg) or 45 mg/m^2 (body weight <45 kg) q4w through study end (week 434).

    Primary: Serum Golimumab Concentrations at Week 6

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    End point title
    		 Serum Golimumab Concentrations at Week 6 [1]
    End point description
    Serum golimumab concentrations at Week 6 in the overall pediatric ulcerative colitis subjects was reported. Pharmacokinetic (PK) analysis set included all enrolled subjects who received at least 1 administration (partial or complete) of study agent and who had one or more PK blood samples obtained after the first golimumab SC injection (partial or complete).Here, N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    pre-dose at Week 6
    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: Only descriptive data was planned to be reported for this endpoint.
    End point values
    		 Golimumab
    Number of subjects analysed
    31
    Units: micrograms per milliliter
        arithmetic mean (standard deviation)
    2.56 ( 1.657 )
    No statistical analyses for this end point

    Secondary: Number of Subjects who Achieved Clinical Response at Week 6

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    End point title
    		 Number of Subjects who Achieved Clinical Response at Week 6
    End point description
    Clinical response was defined as a decrease from baseline in the Mayo score by greater than or equal to (>=) 30 percent (%) and >= to 3 points, with either a decrease from baseline in the rectal bleeding subscore of 1 or more or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values ranged from 0 to 12 scores, where 3 to 5 = mild disease; 6 to 10 = moderate disease; and 11 to 12 = severe disease. Higher scores indicated worsening of the disease. Analysis population included all enrolled subjects who received at least one administration of golimumab.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Golimumab
    Number of subjects analysed
    35
    Units: subjects
    21
    No statistical analyses for this end point

    Secondary: Number of Subjects who Achieved Clinical Remission at Week 6 Measured by the Mayo Score

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    End point title
    		 Number of Subjects who Achieved Clinical Remission at Week 6 Measured by the Mayo Score
    End point description
    Clinical remission was defined as a Mayo score less than or equal to (<=) 2 points, with no individual subscore greater than (>) 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicated worsening of the disease. Analysis population included all enrolled subjects who received at least one administration of golimumab.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Golimumab
    Number of subjects analysed
    35
    Units: subjects
    15
    No statistical analyses for this end point

    Secondary: Number of Subjects who Achieved Clinical Remission at Week 6 Measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) Score

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    End point title
    		 Number of Subjects who Achieved Clinical Remission at Week 6 Measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
    End point description
    Clinical remission as per PUCAI score was defined as PUCAI score of less than (<) 10, a noninvasive measure of ulcerative colitis disease activity. The PUCAI score consists of 6 scales (abdominal pain [points 0 to 10], rectal bleeding [points 0 to 30], stool consistency [points 0 to 10], number of stools [points 0 to 15], nocturnal bowel movement [points 0 to 10], and activity level [points 0 to 10]). The total score ranges from 0 and 85 points, where it was calculated as the sum of the 6 scales and decrease of 20 points was considered a minimally clinically important change. Higher scores indicated a more severe disease. Analysis population included all enrolled subjects who received at least one administration of golimumab.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Golimumab
    Number of subjects analysed
    35
    Units: subjects
    12
    No statistical analyses for this end point

    Secondary: Number of Subjects with Mucosal Healing at Week 6

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    End point title
    		 Number of Subjects with Mucosal Healing at Week 6
    End point description
    Mucosal healing was defined as an endoscopy subscore of the Mayo score of 0 (normal or inactive disease) or 1 (mild disease). The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician’s global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicated worsening of the disease. Analysis population included all enrolled subjects who received at least one administration of golimumab.
    End point type
    Secondary
    End point timeframe
    Week 6
    End point values
    		 Golimumab
    Number of subjects analysed
    35
    Units: subjects
    19
    No statistical analyses for this end point

    Secondary: Number of Subjects who Achieved Clinical Remission at Week 54 and Week 110 Measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) Score

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    End point title
    		 Number of Subjects who Achieved Clinical Remission at Week 54 and Week 110 Measured by Pediatric Ulcerative Colitis Activity Index (PUCAI) Score
    End point description
    Clinical remission as per PUCAI score was defined as PUCAI score of less than (<) 10, a noninvasive measure of ulcerative colitis disease activity. The PUCAI score consists of 6 scales (abdominal pain [points 0 to 10], rectal bleeding [points 0 to 30], stool consistency [points 0 to 10], number of stools [points 0 to 15], nocturnal bowel movement [points 0 to 10], and activity level [points 0 to 10]). The total score ranges from 0 and 85 points, where it was calculated as the sum of the 6 scales and decrease of 20 points is considered a minimally clinically important change. Higher scores indicated a more severe disease. Analysis population included subjects treated with golimumab in study extension part (Week 14 to Week 126) of study. The median change in PUCAI score from Week 110 was maintained at 0.0 at all visits assessed after Week 126. Here, N (number of subjects analysed) signifies subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 54 and Week 110
    End point values
    		 Golimumab
    Number of subjects analysed
    20
    Units: subjects
        Week 54
    11
        Week 110
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to Week 434
    Adverse event reporting additional description
    The safety analysis set included all subjects who received at least 1 dose of study intervention.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Golimumab
    Reporting group description
    		 Subjects with moderately to severely active ulcerative colitis (UC), received subcutaneous (SC) golimumab based on body weight in main part of study that is (i.e.) body weight less than (<) 45 kilogram (kg) received 90 milligrams per meter squared (mg/m^2) (up to maximum of 200 milligrams [mg]) at Week 0 and 45 mg/m^2 (up to maximum of 100 mg) at Week 2. Subjects with body weight greater than or equal to (>=) 45 kg received 200 mg at Week 0 and 100 mg at Week 2. Subjects with clinical response at Week 6 received same previous dose at Weeks 6 and 10. Subjects with clinical response at Week 6 entered study extension part at Week 14 and received maintenance therapy of golimumab 100 mg (body weight >=45 kg) or 45 mg/m^2 (body weight <45 kg) every 4 weeks (q4w) through study end (week 434).

    Serious adverse events
    		 Golimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 35 (45.71%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Forearm Fracture
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Pancreatitis Acute
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    13 / 35 (37.14%)
         occurrences causally related to treatment / all
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholangitis Sclerosing
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 35 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Golimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 35 (85.71%)
    General disorders and administration site conditions
    Injection Site Irritation
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    47
    Injection Site Erythema
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    7
    Fatigue
         subjects affected / exposed
    7 / 35 (20.00%)
         occurrences all number
    15
    Pyrexia
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    4
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Injection Site Pain
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    11
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    9
    Nasal Congestion
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    4
    Oropharyngeal Pain
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    6
    Rhinitis Allergic
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Sinus Congestion
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Investigations
    Weight Decreased
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Ligament Sprain
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Contusion
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Headache
         subjects affected / exposed
    12 / 35 (34.29%)
         occurrences all number
    32
    Dizziness
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 35 (20.00%)
         occurrences all number
    8
    Leukopenia
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    3
    Eye disorders
    Ocular Hyperaemia
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    4
    Colitis Ulcerative
         subjects affected / exposed
    12 / 35 (34.29%)
         occurrences all number
    20
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    6 / 35 (17.14%)
         occurrences all number
    11
    Abdominal Pain
         subjects affected / exposed
    9 / 35 (25.71%)
         occurrences all number
    21
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    7 / 35 (20.00%)
         occurrences all number
    10
    Rectal Haemorrhage
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Vomiting
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    4
    Erythema
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Pruritus
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    5
    Rash
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    7
    Musculoskeletal Chest Pain
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    8
    Influenza
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Herpes Zoster
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Ear Infection
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    6
    Clostridium Difficile Infection
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    4
    Clostridium Difficile Colitis
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Bacterial Infection
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    6
    Upper Respiratory Tract Infection
         subjects affected / exposed
    8 / 35 (22.86%)
         occurrences all number
    19
    Sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    3
    Rhinitis
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Pneumonia
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    3
    Pharyngitis Streptococcal
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    2
    Viral Infection
         subjects affected / exposed
    2 / 35 (5.71%)
         occurrences all number
    3
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 35 (8.57%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    4 / 35 (11.43%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2013
    Subjects in clinical response was continued receiving open-label maintenance therapy with golimumab and had the opportunity to participate in the study extension at Week 14. For subject convenience, the option of at-home golimumab administration is added during the study extension for subjects greater than or equal to (>=) 45 kilograms (kg). Addition of the option of at-home golimumab administration during the study extension for subjects with body weight >=45 kg: This was added for subject convenience. Addition of the option for subjects to decrease their dose to golimumab 50 mg or 22.5 mg/m2 at Week 14 or thereafter at the discretion of the investigator: Once a subject’s dose was reduced, a single dose increase back to 100 mg or 45 mg/m2 was permitted based on the investigator’s assessment of an increase in a subject’s UC disease activity. A more flexible dosage strategy during the study extension allowed investigators to use the lowest effective dose and provided some discretion to investigators to increase the dose to manage the subject’s clinical condition. Collection of a digital image of the screening and Week 6 endoscopies: A digital image of the endoscopy supported documentation of a subject’s disease activity at the time of the assessment of the endoscopic score. Addition of a biomarker evaluation for mucosal biopsy ribonucleic acid (RNA): This analysis enables examination of gene expression associated with pediatric UC. Update of the reference point for the stable concomitant UC therapy inclusion criteria: To minimize the period of time in which subjects were not receiving effective therapy, the reference point for stable concomitant UC therapy was modified from the screening procedures for the Mayo score to the first dose of study agent (Week 0).

    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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