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    Clinical Trial Results:
    The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II

    Summary
    EudraCT number
    		 2007-005464-26
    Trial protocol
    		 GB  
    Global end of trial date
    30 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Apr 2019
    First version publication date
    26 Apr 2019
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    RECrefno07/H0707/114
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Dr Valentina Puntmann, Kings College London, 0044 0207188 7242, v.puntmann@kcl.ac.uk
    Scientific contact
    Dr Valentina Puntmann, Kings College London, 0044 0207188 7242, v.puntmann@kcl.ac.uk
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Valentina Puntmann, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7242, v.puntmann@kcl.ac.uk
    Scientific contact
    Dr Valentina Puntmann, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7242, v.puntmann@kcl.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
    30 Apr 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate TNF-alpha inhibitors altering cardiovascular function in patients with systemic inflammatory conditions (FMD, LV mass/LV volumes)
    Protection of trial subjects
    Patients will be recruited from the respective speciality clinics (rheumatology, gastroenterology), only after clinical diagnoses have been established and the clinical decision on eligibility for anti-TNF therapy has been reached independently by the clinical team in charge of the patient. Clinical decision making will be in line with the recommendations of the NICE guidelines and eligibility specifications outlined in SmPCs of the respective anti-TNF therapies (infliximab, etanercept and adalimumab). This also includes the concomitant medication, such as the use of methotrexate in patients with rheumatoid arthritis. Only adult patients were recruited. Women of childbearing potential needed to provide a negative pregnancy test prior to study entry.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2008
    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: 14
    Worldwide total number of subjects
    14
    EEA total number of subjects
    14
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients will be recruited from the speciality clinics (rheumatology), only after clinical diagnoses have been established and the clinical decision on eligibility for anti-TNF therapy has been reached independently by the clinical team in charge of the patient.

    Pre-assignment
    Screening details
    		 Inclusion criteria in clinical trial: Male and female subjects over 18 years of age. Systemic inflammatory conditions (Rheumatoid arthritis) - diagnosis established independently by the clinical team Eligibility for anti-TNF-α therapy – decision to start treatment will be reached independently by the clinical team.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Remicade
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Total 3mg/Kg

    Arm title
    		 Enbrel
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg milligram(s)

    Number of subjects in period 1
    		Remicade Enbrel
    Started
    9
    5
    Completed
    9
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Remicade
    Reporting group description
    		 -

    Reporting group title
    Enbrel
    Reporting group description
    		 -

    Reporting group values
    		 Remicade Enbrel Total
    Number of subjects
    		 9 5 14
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 9 5 14
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 5 0 5

    End points

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    End points reporting groups
    Reporting group title
    Remicade
    Reporting group description
    		 -

    Reporting group title
    Enbrel
    Reporting group description
    		 -

    Primary: Primary Endpoint

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    End point title
    		 Primary Endpoint [1]
    End point description
    1. Aortic distensibility and stiffness studies (PWV and AD) 2. Myocardial function (LV mass, LV volumes)
    End point type
    Primary
    End point timeframe
    From baseline to 18 months post initiation of anti-TNF therapy
    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: Please see final study report
    End point values
    		 Remicade Enbrel
    Number of subjects analysed
    9
    5
    Units: Subject having PWV and AD
    9
    5
    Attachments
    		 Trial results
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From consent to 18 months after anti-TNF therapy was initiated.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Remicade
    Reporting group description
    		 -

    Reporting group title
    Enbrel
    Reporting group description
    		 -

    Serious adverse events
    		 Remicade Enbrel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Remicade Enbrel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 5 (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: No AEs were reported during the trial

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2009
    Amendment made when study was being conducted by previous sponsor.
    15 Mar 2012
    Change of sponsor from Imperial to King's College London and Guy's and St. Thomas' NHS Foundation Trust
    24 May 2012
    The addition of IMP Certolizumab pegol (Cimzia) as this has become the first line agent in treating rheumatoid patients at St. Thomas’ Hospital. Addition of “demyelinating disease” to the listed exclusion criteria, this is listed as a precaution for use in the Cimzia SmPC dated 14/01/2013.

    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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