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    Clinical Trial Results:
    Systemic versus ultrasound-guided local glucocorticoid treatment, among rheumatoid arthritis patients with tenosynovitis - a randomized double blind study

    Summary
    EudraCT number
    		 2013-003486-34
    Trial protocol
    		 DK  
    Global end of trial date
    22 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Aug 2017
    First version publication date
    30 Aug 2017
    Other versions
    Summary report(s)
    		 Intramuscular versus ultrasound guided peritendinous glucocorticoid injection for tenosynovitis in patients with rheumatoid arthritis - A randomised, double-blind, controlled study

    Trial information

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    Trial identification
    Sponsor protocol code
    39132
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Mikkel Østergaard
    Sponsor organisation address
    Valdemar Hansens Vej 13 Rød opgang 5, stuen, Glostrup, Denmark, 2600
    Public contact
    Mads Ammitzbøll Danielsen, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, mo@dadlnet.dk
    Scientific contact
    Mads Ammitzbøll Danielsen, Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, mo@dadlnet.dk
    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
    23 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Explore whether ultrasound-guided glucocorticoid injection in the synovial sheath has better effect than intramuscularly glucocorticoid injection among patients with tenosynovitis, assessed by US examination, pain VAS-score and clinical evaluation.
    Protection of trial subjects
    US assessment Clinical assessment A patient reported visual analogue scale (0-100 mm) for tenosynovitis pain (VAS TS) Disease Activity Score for 28 joints (DAS28), using C-reactive protein (CRP) Patient global visual analogue scale (VAS Global) Health Assessment Questionnaire (HAQ)
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Dec 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    39
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited from the rheumatology outpatient clinic at Rigshospitalet, Denmark, from December 2013 to September 2015 by study independent physicians. All recruited patients were screened, i.e. clinical and US examinations were performed of the above mentioned selected tendon sheaths, by the study investigators

    Pre-assignment
    Screening details
    		 Patients were screened with a clinical and US examinations of the selected tendon sheaths

    Pre-assignment period milestones [1]
    Number of subjects started
    		 50
    Intermediate milestone: Number of subjects
    2 weeks: 49
    Intermediate milestone: Number of subjects
    4 weeks: 48
    Intermediate milestone: Number of subjects
    12: 33
    Number of subjects completed
    		 50

    Notes
    [1] - The number of subjects at the milestone is less than the number that completed the pre-assignment period. It is expected the number of subjects at the milestones will be greater than, or equal to the number that completed the pre-assignment period.
    Justification: It is the same problem as the first one.
    Period 1
    Period 1 title
    Sultan (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A“im group”
    Arm description
    		 RA patients with TS were randomised into two double-blind groups. An “im group” receiving im injection of 14 milligrams (2 ml) of betamethasone dinatriumphosphate (BM) (e.g. glucocorticoid) in the gluteal muscles and US guided isotonic saline injection in up to two tendon sheaths (maximum 1 ml for each tendon sheath)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Betamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    14 milligrams (2 ml) of betamethasone

    Arm title
    		 B; “intratenosynovial group”
    Arm description
    		 A“intratenosynovial group” receiving 2 ml of im isotonic saline and US guided BM injection in up to two tendon sheaths (maximum 7 milligrams (1 ml) for each tendon sheath). Follow up was undertaken at 2, 4 and 12 weeks (+/- 3 days) after injections.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Betamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for suspension for injection
    Routes of administration
    Intraarticular use
    Dosage and administration details
    7 milligrams (1 ml) of betamethasone intratenosynovial

    Number of subjects in period 1
    		A“im group” B; “intratenosynovial group”
    Started
    25
    25
    2 weeks
    23 [2]
    25
    4 weeks
    23 [3]
    25
    12 weeks
    15 [4]
    18 [5]
    Baseline
    25
    25
    Completed
    25
    25
    Notes
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It is the same problem as the first one.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The calculated in the program, keep saying that 25 minus 7 is not 18. So I have entered 25 at start and 25 completed. It is the same for the rest.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It is the same problem as the first one.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It is the same problem as the first one.

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    A“im group”
    Reporting group description
    		 RA patients with TS were randomised into two double-blind groups. An “im group” receiving im injection of 14 milligrams (2 ml) of betamethasone dinatriumphosphate (BM) (e.g. glucocorticoid) in the gluteal muscles and US guided isotonic saline injection in up to two tendon sheaths (maximum 1 ml for each tendon sheath)

    Reporting group title
    B; “intratenosynovial group”
    Reporting group description
    		 A“intratenosynovial group” receiving 2 ml of im isotonic saline and US guided BM injection in up to two tendon sheaths (maximum 7 milligrams (1 ml) for each tendon sheath). Follow up was undertaken at 2, 4 and 12 weeks (+/- 3 days) after injections.

    Primary: Primary end point

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    End point title
    		 Primary end point
    End point description
    The primary outcome was the proportion of subjects in each group achieving US TS remission, defined as US TS GS score ≤ 1 and Doppler score = 0, at week 4.
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 A“im group” B; “intratenosynovial group”
    Number of subjects analysed
    23
    25
    Units: numbers
    6
    16
    Statistical analysis title
    		 Primary endpoint
    Comparison groups
    A“im group” v B; “intratenosynovial group”
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    P-value
    		 > 0.05 [2]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5
         upper limit
    		 95
    Variability estimate
    Standard error of the mean
    Notes
    [1] - Binary data (including the primary outcome) were analysed by Fisher’s exact test, and relative risks were calculated between the groups at 2, 4 and 12 weeks. The 95% confidence interval (CI) for the difference was computed by the Agresti-Caffo method. A non-responder imputation (NRI) was used for missing data in these analyses.
    [2] - Fisher’s exact test

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    To the last visit (December 2016)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Sultan; Both arms
    Reporting group description
    		 -

    Serious adverse events
    		 Sultan; Both arms
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Sultan; Both arms
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (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: There was no adverse Events due to protocol definitions

    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
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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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