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    Clinical Trial Results:
    The Standard care versus Celecoxib Outcome Trial (SCOT): A Large Streamlined Safety Study Dansk: Klinisk forsøg med standardbehandling versus celecoxib (SCOT-forsøget) Et stort, strømlinet forsøg i lægemiddelsikkerhed

    Summary
    EudraCT number
    		 2007-000012-90
    Trial protocol
    		 GB   DK   NL  
    Global end of trial date
    28 Aug 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Aug 2017
    First version publication date
    04 Aug 2017
    Other versions
    Summary report(s)
    		 SCOT Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    9.6(v16)
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00447759
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The University of Dundee
    Sponsor organisation address
    Nethergate, Dundee, United Kingdom, DD1 4HN
    Public contact
    Dr Catrina Forde (Senior Research Governance Manager), The University of Dundee, 01382 383890, c.forde@dundee.ac.uk
    Scientific contact
    Dr Catrina Forde (Senior Research Governance Manager), The University of Dundee, 01382 383890, c.forde@dundee.ac.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
    28 Aug 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Aug 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the cardiovascular safety of celecoxib and traditional NSAIDs prescribed for the treatment of arthritis.
    Protection of trial subjects
    All subjects were treated in normal care by family physicians. The intervention randomised subjects to continue to receive their standard non selective non-steroidal anti-inflammatory drug (nsNSAID) or to switch to celecoxib both prescribed in usual care.
    Background therapy
    		 All subjects received nsNSAID at baseline prescribed for osteoarthritis or rheumatoid arthritis.
    Evidence for comparator
    		 The purpose of the trial was to compare the cardiovascular safety of celecoxib, an effective selective cyclo-oxygenase 2 inhibtor with non-selective cyclooxygenase inhibitors (nsNSAIDs)
    Actual start date of recruitment
    29 Jan 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 5045
    Country: Number of subjects enrolled
    Denmark: 2209
    Country: Number of subjects enrolled
    Netherlands: 43
    Worldwide total number of subjects
    7297
    EEA total number of subjects
    7297
    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)
    0
    From 65 to 84 years
    7297
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects aged 60 or over and free from established cardiovascular disease and who were taking chronic nsNSAIDs for osteoathritis or rheumatoid arthritis were identified in primary care and invited to participate.

    Pre-assignment
    Screening details
    		 Subjects underwent screening by a study nurse including baseline bloods to exclude significant renal or hepatic dysfunction. The full study protocol is published at: bmjopen-2012-002295

    Pre-assignment period milestones
    Number of subjects started
    		 7297
    Number of subjects completed
    		 7297

    Period 1
    Period 1 title
    Screening (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Investigator, Data analyst, Assessor [2]
    Blinding implementation details
    The study was a Prospective Open Blinded-end-point (PROBE) design.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Standard NSAID
    Arm description
    		 Subjects in this arm continued their baseline nsNSAID
    Arm type
    		 Active comparator

    Investigational medicinal product name
    nsNSAID
    Investigational medicinal product code
    Other name
    Any licenced nsNSAID except COX2 selective NSAIDs
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Any licenced dose of and nsNSAID

    Arm title
    		 Celecoxib
    Arm description
    		 Subjects switched from standard NSAID to celecoxib prescribing
    Arm type
    		 Experimental

    Investigational medicinal product name
    celecoxib
    Investigational medicinal product code
    Other name
    celebrex
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Any licenced dose could be prescribed

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: This was a Prospective Open Blinded End Point (PROBE) design
    [2] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a Prospective Open Blinded End-point study (PROBE) design
    Number of subjects in period 1
    		Standard NSAID Celecoxib
    Started
    3650
    3647
    Completed
    3650
    3647

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard NSAID
    Reporting group description
    		 Subjects in this arm continued their baseline nsNSAID

    Reporting group title
    Celecoxib
    Reporting group description
    		 Subjects switched from standard NSAID to celecoxib prescribing

    Reporting group values
    		 Standard NSAID Celecoxib Total
    Number of subjects
    		 3650 3647 7297
    Age categorical
    Units: Subjects
        Age 60+
    		 3650 3647 7297
    Age continuous
    Age 60 or over
    Units: years
        arithmetic mean (standard deviation)
    		 68.2 ( 6.1 ) 68.6 ( 6.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2218 2120 4338
        Male
    		 1432 1527 2959
    Type or arthritis
    Units: Subjects
        Osteoarthritis
    		 3422 3421 6843
        Rheumatoid
    		 228 226 454
    Mean age
    Units: years
        arithmetic mean (standard deviation)
    		 68.2 ( 6.1 ) 68.6 ( 6.2 ) -
    Subject analysis sets

    Subject analysis set title
    Standard NSAID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects switched to celecoxib

    Subject analysis set title
    Celecoxib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects continuing with nsNSAID

    Subject analysis sets values
    		 Standard NSAID Celecoxib
    Number of subjects
    3650
    3647
    Age categorical
    Units: Subjects
        Age 60+
    3650
    3647
    Age continuous
    Age 60 or over
    Units: years
        arithmetic mean (standard deviation)
    68.2 ( 6.1 )
    68.6 ( 6.2 )
    Gender categorical
    Units: Subjects
        Female
        Male
    Type or arthritis
    Units: Subjects
        Osteoarthritis
        Rheumatoid
    Mean age
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )

    End points

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    End points reporting groups
    Reporting group title
    Standard NSAID
    Reporting group description
    		 Subjects in this arm continued their baseline nsNSAID

    Reporting group title
    Celecoxib
    Reporting group description
    		 Subjects switched from standard NSAID to celecoxib prescribing

    Subject analysis set title
    Standard NSAID
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects switched to celecoxib

    Subject analysis set title
    Celecoxib
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects continuing with nsNSAID

    Primary: APTC Composite

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    End point title
    		 APTC Composite
    End point description
    Time to first event
    End point type
    Primary
    End point timeframe
    Mean 3.2 yeas
    End point values
    		 Standard NSAID Celecoxib
    Number of subjects analysed
    3650 [1]
    3647 [2]
    Units: subjects
        APTC Composite
    124
    125
    Attachments
    		 Untitled (Filename: ITT Analysis.doc)
    Notes
    [1] - nsNSAID
    [2] - celecoxib
    Statistical analysis title
    		 Primary Analysis
    Statistical analysis description
    Time to first APTC endpoint
    Comparison groups
    Standard NSAID v Celecoxib
    Number of subjects included in analysis
    7297
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 < 0.05
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    1.04
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.33
    Variability estimate
    Standard deviation
    Notes
    [3] - NI margin 1.4

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    At end of trial
    Adverse event reporting additional description
    Only treatment related asverse reactions captured but all SAEs
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    nsNSAIDs
    Reporting group description
    		 Stayed on prescribed NSAID

    Reporting group title
    celecoxib
    Reporting group description
    		 Subjects switched to celecoxib

    Serious adverse events
    		 nsNSAIDs celecoxib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1183 / 3650 (32.41%)
    1155 / 3647 (31.67%)
         number of deaths (all causes)
    41
    35
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Any SAE
         subjects affected / exposed
    1183 / 3650 (32.41%)
    1155 / 3647 (31.67%)
         occurrences causally related to treatment / all
    0 / 1183
    0 / 1155
         deaths causally related to treatment / all
    0 / 116
    0 / 102
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 nsNSAIDs celecoxib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    586 / 3650 (16.05%)
    804 / 3647 (22.05%)
    Cardiac disorders
    All no-serious
         subjects affected / exposed
    586 / 3650 (16.05%)
    804 / 3647 (22.05%)
         occurrences all number
    586
    804

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2015
    Relaxation of the non-inferiority margin from 1.3 to 1.4 due to the very low (0.9%) event rate.

    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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