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    Clinical Trial Results:
    T cells and TNF: The impact of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents.

    Summary
    EudraCT number
    		 2009-012424-87
    Trial protocol
    		 GB  
    Global end of trial date
    21 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Dec 2019
    First version publication date
    27 Dec 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2104091
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01060098
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Dr Sonya Abraham, Imperial College London, +44 (0)20 3313 4114, s.abraham@imperial.ac.uk
    Scientific contact
    Dr Sonya Abraham, Imperial College London, +44 (0)20 3313 4114, s.abraham@imperial.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
    02 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of our research is to determine the effect of anti-TNF-alpha treatment on the levels of a cell type of the immune system, called Th17 cells and their product, IL-17 in blood samples and joint biopsies from patients with rheumatoid arthritis at different time points during treatment and how these changes correlate with parameters of systemic and local disease activity.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2010
    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: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from Imperial College Healthcare NHS Trust clinics.

    Pre-assignment
    Screening details
    		 48 participants were eligible

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rheumatoid arthritis
    Arm description
    		 Participants diagnosed with Rheumatoid arthritis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Other name
    Etanercept
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg

    Arm title
    		 Ankylosing spondylitis
    Arm description
    		 Participants diagnosed with Ankylosing spondylitis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Other name
    Etanercept
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg

    Arm title
    		 Psoriatic arthritis
    Arm description
    		 Participants diagnosed with
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Other name
    Etanercept
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg

    Number of subjects in period 1
    		Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis
    Started
    25
    15
    8
    Completed
    25
    15
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rheumatoid arthritis
    Reporting group description
    		 Participants diagnosed with Rheumatoid arthritis

    Reporting group title
    Ankylosing spondylitis
    Reporting group description
    		 Participants diagnosed with Ankylosing spondylitis

    Reporting group title
    Psoriatic arthritis
    Reporting group description
    		 Participants diagnosed with

    Reporting group values
    		 Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis Total
    Number of subjects
    		 25 15 8 48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 25 15 8 48
        From 65-84 years
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 57.4 ( 11.7 ) 36.4 ( 11.8 ) 50.9 ( 8.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 3 5 26
        Male
    		 7 12 3 22

    End points

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    End points reporting groups
    Reporting group title
    Rheumatoid arthritis
    Reporting group description
    		 Participants diagnosed with Rheumatoid arthritis

    Reporting group title
    Ankylosing spondylitis
    Reporting group description
    		 Participants diagnosed with Ankylosing spondylitis

    Reporting group title
    Psoriatic arthritis
    Reporting group description
    		 Participants diagnosed with

    Subject analysis set title
    Baseline Rheumatoid arthritis
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Baseline of the Rheumatic arthritis participants

    Subject analysis set title
    Baseline ankylosing spondylitis
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Baseline of the Ankylosing spondylitis participants

    Subject analysis set title
    Baseline Psoriatic arthritis
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Baseline of Psoriatic arthritis participants

    Primary: Measurement of Effector T Helper Type 17 Cells in Peripheral Blood

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    End point title
    		 Measurement of Effector T Helper Type 17 Cells in Peripheral Blood
    End point description
    The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).
    End point type
    Primary
    End point timeframe
    0 and 12 weeks
    End point values
    		 Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis Baseline Rheumatoid arthritis Baseline ankylosing spondylitis Baseline Psoriatic arthritis
    Number of subjects analysed
    25
    15
    8
    25
    15
    8
    Units: spSCF/10^6
        arithmetic mean (standard error)
    759.8 ( 510 )
    651 ( 532 )
    609 ( 373 )
    466.4 ( 277 )
    432 ( 474 )
    450 ( 276 )
    Statistical analysis title
    		 Rheumatoid Arthritis
    Comparison groups
    Rheumatoid arthritis v Baseline Rheumatoid arthritis
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Ankylosing Spondylitis
    Comparison groups
    Ankylosing spondylitis v Baseline ankylosing spondylitis
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Psoriatic Arthritis
    Comparison groups
    Psoriatic arthritis v Baseline Psoriatic arthritis
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.48
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Rheumatoid arthritis
    Reporting group description
    		 Participants diagnosed with Rheumatoid arthritis

    Reporting group title
    Ankylosing spondylitis
    Reporting group description
    		 Participants diagnosed with Ankylosing spondylitis

    Reporting group title
    Psoriatic arthritis
    Reporting group description
    		 Participants diagnosed with

    Serious adverse events
    		 Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Rheumatoid arthritis Ankylosing spondylitis Psoriatic arthritis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 15 (0.00%)
    0 / 8 (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 adverse events reported

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25766640
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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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