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    Clinical Trial Results:
    An open label study of intra-articular steroid injection in the management of symptomatic knee OA

    Summary
    EudraCT number
    		 2009-015849-22
    Trial protocol
    		 GB  
    Global end of trial date
    11 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions
    Summary report(s)
    		 TASK Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    2009/147
    Additional study identifiers
    ISRCTN number
    		 ISRCTN07329370
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Salford Royal NHS Foundation Trust
    Sponsor organisation address
    Stott Lane , Salford, United Kingdom, M6 8HD
    Public contact
    Professor Terence O'Neill, University of Manchester, +44 1612064627, Terence.o'Neill@srft.nhs.uk
    Scientific contact
    Professor Terence O'Neill, University of Manchester, +44 1612064627, Terence.o'Neill@srft.nhs.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
    26 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine i) whether clinical response to intra-articular steroids in knee OA correlates with a decrease in size and a decrease in perfusion of the synovium. and ii) whether relapse of symptoms after intra-articular steroids is associated with recurrence of synovitis.
    Protection of trial subjects
    Treatment given within clinical trial setting as part of routine clinical care. All adverse events reported descriptively and reviewed by CI & Sponsor.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 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: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment details: Participants meeting eligibility criteria were recruited from a single site in England between 11/05/2010 to 15/12/2014.

    Pre-assignment
    Screening details
    		 Patients screened for eligibility by the research team and were referred from a patient identifiable centre

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

    Arms
    Arm title
    		 overall trial
    Arm description
    		 Standard care
    Arm type
    		 standard care

    Investigational medicinal product name
    Depomedrone
    Investigational medicinal product code
    402AB04
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    80mg

    Number of subjects in period 1
    		overall trial
    Started
    120
    Completed
    120

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 120 120
    Age categorical
    Adults between 40 to 79
    Units: Subjects
        Adults (18-64 years)
    		 120 120
    Gender categorical
    Units: Subjects
        Female
    		 74 74
        Male
    		 46 46

    End points

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    End points reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 Standard care

    Subject analysis set title
    overall trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    overall trial analysis

    Primary: Pain Score

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    End point title
    		 Pain Score
    End point description
    End point type
    Primary
    End point timeframe
    From Baseline to final follow-up
    End point values
    		 overall trial overall trial
    Number of subjects analysed
    120
    120
    Units: VAS
    arithmetic mean (standard deviation)
        VAS
    3.30 ± 2.7
    3.30 ± 2.7
    Attachments
    		 Table 2
    Statistical analysis title
    		 overall trial
    Statistical analysis description
    see publication
    Comparison groups
    overall trial v overall trial
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 = 0.001
    Method
    		 Stata
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.7
         upper limit
    		 3.8
    Variability estimate
    Standard deviation
    Dispersion value
    3.3
    Notes
    [1] - see publication

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs and SAE’s shall be recorded from the time a participant consents to join the study until the last study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Treatment Arm
    Reporting group description
    		 They had a contrastenhanced (CE) MRI immediately prior to an intraarticularsteroid injection with a repeat scan within20 days.

    Serious adverse events
    		 Treatment Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 120 (1.67%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 120 (41.67%)
    General disorders and administration site conditions
    pain
         subjects affected / exposed
    50 / 120 (41.67%)
         occurrences all number
    50

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Feb 2010
    This extended the study to include patients who had had either an MRI, Arthroscopy or X ray in the previous 24 months
    22 Jul 2010
    Removal of upper age limit; Reduction of wash out period; Alternative recruitment strategies; Use of telephone screening questionnaire for patients who contact via advertising
    28 Jan 2011
    Addition of recruitment letters and a questionnaire to facilitate a more effective recruitment strategy through GP practices; Change to inclusion criteria; change to time between screening, baseline and week one appointments; use of ultrasound has been added to the protocol...
    22 Sep 2011
    Addition of Sub Study – KOPS
    12 Apr 2012
    To allow the recruitment of additional 80 participants for collection of new baseline information on other predictors to intra-articular steroid injection in knee OA (CLIPs sub-study). The study already has sufficient data on structural changes assessed by magnetic resonance imaging (MRI) scan. Therefore, the extension of the study will involve removal of MRI and hence blood test (eGFR) will not be needed for screening of renal function.
    27 Feb 2013
    To allow telephone review call window of 28 +/- 14 (i.e. between 14 days and 42 days), instead of every 2 weeks to accommodate times when research nurse or participants may be unavailable for the reviews. The PIS will also include additional clause inviting participants to contact the research team if their pain changes. Some of the other changes are for clarity and also for administrative reasons rather than changes to the actual conduct of the study.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26116548
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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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