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    Clinical Trial Results:
    Study of the Golimumab Exposure-Response Relationship using Serum Trough Levels

    Summary
    EudraCT number
    		 2017-001374-42
    Trial protocol
    		 GB  
    Global end of trial date
    15 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions
    Summary report(s)
    		 Clinical Study report

    Trial information

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    Trial identification
    Sponsor protocol code
    3573
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03124121
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE1 9RT
    Public contact
    Dr Peter Irving, Guy's and St Thomas' NHS Foundation Trust, +44 02071882499, peter.irving@gstt.nhs.uk
    Scientific contact
    Dr Peter Irving, Guy's and St Thomas' NHS Foundation Trust, +44 02071882499, peter.irving@gstt.nhs.uk
    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 Feb 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define a week 6 golimumab trough level concentration that predicts response at week 14.
    Protection of trial subjects
    Patients are free to withdraw consent for study treatment and/or consent to participate in the study at any time and without the prejudice to further treatment. Patients who withdraw from study treatment, but are willing to continue to participate in the follow-up visits, should be followed according to the procedures outlined in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2017
    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
    United Kingdom: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    109
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Potential participants were identified by members of the multidisciplinary direct care team. Potential participants were discussed at a multidisciplinary meeting where appropriateness for enrollment was assessed.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Golimumab Induction cohort
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive standard golimumab induction treatment of 200 mg at week 0 and 100 mg at week 2, according to standard clinical practice. From week 6 maintenance treatment is started at 100 mg (≥ 80 kg) or 50 mg (< 80 kg) every four weeks. Treatment will be continued until the supervising clinician makes the decision to withdraw treatment (exactly as the standard of care).

    Arm title
    		 Golimumab maintenance cohort
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients will receive standard golimumab induction treatment of 200 mg at week 0 and 100 mg at week 2, according to standard clinical practice. From week 6 maintenance treatment is started at 100 mg (≥ 80 kg) or 50 mg (< 80 kg) every four weeks. Treatment will be continued until the supervising clinician makes the decision to withdraw treatment (exactly as the standard of care).

    Number of subjects in period 1
    		Golimumab Induction cohort Golimumab maintenance cohort
    Started
    42
    70
    Completed
    38
    66
    Not completed
    4
    4
         Disease progression
    2
    -
         Adverse event, non-fatal
    1
    -
         sample unsuitable for analysis
    -
    1
         Protocol deviation
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 112 112
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 109 109
        From 65-84 years
    		 3 3
        85 years and over
    		 0 0
        Overall
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 47 47
        Male
    		 65 65

    End points

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    End points reporting groups
    Reporting group title
    Golimumab Induction cohort
    Reporting group description
    		 -

    Reporting group title
    Golimumab maintenance cohort
    Reporting group description
    		 -

    Primary: UC disease activity (SCCAI) at weeks 6 and 10

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    End point title
    		 UC disease activity (SCCAI) at weeks 6 and 10 [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    baseline, week 6, week 10
    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: As this is a single arm study, EudraCT limitations would not allow the statistical analysis to be posted. Please see the attached summary report for statistical analyses.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Cohorts were analysed separately
    End point values
    		 Golimumab Induction cohort
    Number of subjects analysed
    38
    Units: SCCAI score
    median (full range (min-max))
        baseline
    8 (5 to 15)
        week 6
    2 (0 to 12)
        week 10
    1.5 (0 to 12)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Injection site reactions and SAEs collected from Day 0 to Day 98
    Adverse event reporting additional description
    AE’s will not be collected during the study period but will be managed as per the standard of care. Only injection-site reactions will be collected as AR’s during the trial period. They will be managed as per the standard of care
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    golimumab
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: AE’s will not be collected during the study period but will be managed as per the standard of care. Only injection-site reactions will be collected as AR’s during the trial period. They will be managed as per the standard of care.
    Serious adverse events
    		 golimumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 112 (3.57%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Acute pancreatitis
    Additional description: Azathioprine induced acute pancreatitis
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Acute ulcerative colitis
         subjects affected / exposed
    2 / 112 (1.79%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Joint infection
         subjects affected / exposed
    1 / 112 (0.89%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 golimumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 112 (0.00%)

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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