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    Clinical Trial Results:
    Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis (SMART)

    Summary
    EudraCT number
    		 2014-000656-29
    Trial protocol
    		 BE  
    Global end of trial date
    05 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Sep 2016
    First version publication date
    10 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-8259-027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02155335
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    05 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to determine whether participants with ulcerative colitis prefer to administer golimumab using the SmartJect® autoinjector, using a prefilled syringe, or are undecided.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2014
    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
    Belgium: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    93
    From 65 to 84 years
    6
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Anti-Tumor necrosis factor (TNF) naïve with established diagnosis of ulcerative colitis (UC) and anti-TNF experienced adults with established diagnosis of UC were enrolled in the study. Other inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prefilled Syringe→Smartject™ Device
    Arm description
    		 Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prefilled Syringe delivery of Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg subcuntaneous injection using prefilled syringe

    Investigational medicinal product name
    Smartject Device delivery of 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
    Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

    Arm title
    		 Smartject™ Device→ Prefilled Syringe
    Arm description
    		 Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prefilled Syringe delivery of Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg subcuntaneous injection using prefilled syringe

    Investigational medicinal product name
    Smartject Device delivery of 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
    Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

    Number of subjects in period 1
    		Prefilled Syringe→Smartject™ Device Smartject™ Device→ Prefilled Syringe
    Started
    50
    50
    Treated
    50
    49
    Completed
    50
    49
    Not completed
    0
    1
         Withdrew prior to treatment
    -
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prefilled Syringe→Smartject™ Device
    Arm description
    		 Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prefilled Syringe delivery of Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg subcuntaneous injection using prefilled syringe

    Investigational medicinal product name
    Smartject Device delivery of 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
    Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

    Arm title
    		 Smartject™ Device→ Prefilled Syringe
    Arm description
    		 Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Smartject Device delivery of 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
    Golimumab 50 mg solution for subcutaneous injection using Smartject Device.

    Investigational medicinal product name
    Prefilled Syringe delivery of Golimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Golimumab 50 mg subcuntaneous injection using prefilled syringe

    Number of subjects in period 2
    		Prefilled Syringe→Smartject™ Device Smartject™ Device→ Prefilled Syringe
    Started
    50
    49
    Completed
    50
    49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 -

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 100 100
    Age Categorical
    Units: Subjects
        Between 18 and 65 years
    		 93 93
        >=65 years
    		 7 7
    Gender Categorical
    Units: Subjects
        Female
    		 43 43
        Male
    		 57 57

    End points

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    End points reporting groups
    Reporting group title
    Prefilled Syringe→Smartject™ Device
    Reporting group description
    		 Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.

    Reporting group title
    Smartject™ Device→ Prefilled Syringe
    Reporting group description
    		 Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
    Reporting group title
    Prefilled Syringe→Smartject™ Device
    Reporting group description
    		 Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.

    Reporting group title
    Smartject™ Device→ Prefilled Syringe
    Reporting group description
    		 Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant then is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.

    Subject analysis set title
    Per Protocol Set
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All enrolled participants who met all inclusionand none of the exclusion criteria, receivedall four injections of golimumab according to the protocol, and completed the device preference questionnaire.

    Primary: Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or are Undecided (Day of Injections)

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    End point title
    		 Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or are Undecided (Day of Injections) [1]
    End point description
    Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant is then administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Following the completion of the last injection, the participants completed a questionnaire in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
    End point type
    Primary
    End point timeframe
    Day 0 (post last injection)
    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 statistical analysis was planned for this endpoint.
    End point values
    		 Per Protocol Set
    Number of subjects analysed
    91
    Units: Percentage of Particpants
    number (not applicable)
        Preferred Prefilled Syringe
    20.9
        Preferred Smatject Device
    76.9
        Undecided
    2.2
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or are Undecided (2 weeks Post Injections)

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    End point title
    		 Percentage of Participants Who Prefer Prefilled Syringe, Smartject™ Device, or are Undecided (2 weeks Post Injections) [2]
    End point description
    Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treatingphysician). Participant then is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants completed a questionnaire 2 weeks after the injections in which they indicated if they preferred the syringe, the Smartject or were undecided as to which they preferred.
    End point type
    Primary
    End point timeframe
    Day 14 (2 weeks post injections)
    Notes
    [2] - 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 statistical analysis was planned for this endpoint.
    End point values
    		 Per Protocol Set
    Number of subjects analysed
    91
    Units: Percentage of Participants
    number (not applicable)
        Preferred Prefilled Syringe
    26.4
        Preferred Smatject Device
    71.4
        Undecided
    2.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    up to 14 days post injections
    Adverse event reporting additional description
    Population included all participants who received at least 1 injection of golimumab and were reported as 1 treatment group regardless of injection sequence.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    All Treated Participants
    Reporting group description
    		 All participants who received at least 1 injection from either prefilled syringe or Smartject

    Serious adverse events
    		 All Treated Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All Treated Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99 (0.00%)
    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: None of the reported non-serious adverse events eclipsed the 5% frequency threshold.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2015
    Amendment 1: Primary reason for the amendment was to clarify the criteria that had to be met prior to initiating first line anti-TNF treatment.

    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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