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    Clinical Trial Results:
    An Open-labelled, Single-arm, Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects with Rheumatoid Arthritis

    Summary
    EudraCT number
    		 2014-004887-39
    Trial protocol
    		 PL  
    Global end of trial date
    08 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Dec 2018
    First version publication date
    28 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SB5-G21-RA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02326233
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Samsung Bioepis Co., Ltd.
    Sponsor organisation address
    107, Cheomdan-daero, Yeonsu-gu, Incheon, Korea, Republic of,
    Public contact
    Information Desk, Samsung Bioepis Co., Ltd., 82 032 455 3114, bioepisinfo@samsung.com
    Scientific contact
    Information Desk, Samsung Bioepis Co., Ltd., 82 032 455 3114, bioepisinfo@samsung.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
    08 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate the comparability between subcutaneous (SC) delivery administration of SB5 via the pre-filled pen (Pen) versus the pre-filled syringe (PFS) in terms of injection site pain in subjects with rheumatoid arthritis (RA).
    Protection of trial subjects
    The study and clinical study protocols were reviewed and approved by Independent Ethics Committee (IEC) or Institutional Review Board (IRB). This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki (2008) and that are consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6) and applicable local regulatory requirements and laws. The nature and purpose of the study was fully explained to each subject and written informed consent was obtained at Screening from each subject before any study related procedures were performed. The consent documents for the study was reviewed and approved by the appropriate IEC or IRB prior to use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2015
    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
    Poland: 49
    Worldwide total number of subjects
    49
    EEA total number of subjects
    49
    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)
    49
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 49 subjects enrolled, 48 (98.0%) subjects completed 6 weeks of treatment. Prior to Week 6, one (2.0%) subject withdrew from the study due to withdrawal of consent. These 48 (98.0%) subjects completed the 12 weeks of treatment as well as the study. No subjects withdrew from the study after Week 6.

    Pre-assignment period milestones
    Number of subjects started
    		 49
    Number of subjects completed
    		 49

    Period 1
    Period 1 title
    Open-label, single arm (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 SB5 Pen/PFS
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB5
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen, Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.8 mL in 50 mg/mL solution for sc injection provided in Pen or PFS. 40 mg sc injection via PFS at Week 0 and Week 2 and then 40 mg sc injection via Pen st Week 4 and then every other week thereafter up to Week 10.

    Number of subjects in period 1
    		SB5 Pen/PFS
    Started
    49
    Completed
    48
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Open-label, single arm
    Reporting group description
    		 -

    Reporting group values
    		 Open-label, single arm Total
    Number of subjects
    		 49 49
    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)
    		 49 49
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.9 ( 9.08 ) -
    Gender categorical
    Units: Subjects
        Female
    		 39 39
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    SB5 Pen/PFS
    Reporting group description
    		 -

    Primary: The change in injection site pain score using an 11-point visual numeric scale

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    End point title
    		 The change in injection site pain score using an 11-point visual numeric scale [1]
    End point description
    End point type
    Primary
    End point timeframe
    Difference of injection site pain score (Week 6 - Week 2)
    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: There is only one group (SB5 PFS then change to SB5 Pen) therefore it is impossible to enter values in statistical methods page (At least two comparison groups are needed to proceed entering the page). Equivalence between two dosing regimens was declared if the 97.5% confidence interval (CI) of the difference in the injection site pain score was entirely contained within the equivalence margin of ±5 with pre-defined alpha level of 0.025 for both the timepoints, i.e. overall alpha level was 0.05.
    End point values
    		 SB5 Pen/PFS
    Number of subjects analysed
    49
    Units: Difference
    number (confidence interval 97.5%)
        Immediately post-injection
    -0.35 (-0.99 to 0.30)
        15-30min post-injection
    -0.11 (-0.47 to 0.25)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    20 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    SB5 PFS/Pen
    Reporting group description
    		 -

    Serious adverse events
    		 SB5 PFS/Pen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (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
    		 SB5 PFS/Pen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 49 (8.16%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 49 (8.16%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Dec 2014
    Administrative change: 11-point numeric rating scale was changed to 11-point visual numeric scale with other administrative changes and editorial changes

    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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    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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