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    Clinical Trial Results:
    Randomized placebo-controlled trial to investigate clinical efficacy, anti-inflammatory properties and safety of prednisolone in hand osteoarthritis: a proof-of-concept study

    Summary
    EudraCT number
    		 2015-000687-33
    Trial protocol
    		 NL  
    Global end of trial date
    02 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2022
    First version publication date
    19 Mar 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOPE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Netherlands Trial Registry: NTR5263
    Sponsors
    Sponsor organisation name
    Leiden University Medical Center
    Sponsor organisation address
    Albinusdreef 2, Leiden, Netherlands,
    Public contact
    Principal investigator, Leiden University Medical Center, 0031 715263598,
    Scientific contact
    Principal investigator, Leiden University Medical Center, 0031 715263598,
    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 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.
    Protection of trial subjects
    Trial subjects were monitored very well during the study.
    Background therapy
    		 Usual care
    Evidence for comparator
    		 Since local inflammation is recognised as contributing to osteoarthritic complaints, the Hand Osteoarthritis Prednisolone Efficacy (HOPE) study aimed to investigate the efficacy and safety of short-term prednisolone in patients with painful hand osteoarthritis and synovial inflammation
    Actual start date of recruitment
    03 Dec 2015
    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
    Netherlands: 92
    Worldwide total number of subjects
    92
    EEA total number of subjects
    92
    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)
    70
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 We recruited eligible adults from rheumatology outpatient clinics at two sites in the Netherlands.

    Pre-assignment
    Screening details
    		 Symptomatic hand OA that fulfilled the ACR criteria and signs of inflammation in DIP/PIP joints. Required to have four or more DIP/PIP joints with OA nodes, >=1 DIP/PIP with soft swelling or erythema, >=1 DIP/PIP with positive power Doppler signal or synovial thickening >=grade 2, pain >=30/100 on VAS that flared after NSAID washout.

    Period 1
    Period 1 title
    overall trial (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
    Blinding implementation details
    Study medication (5 mg/mL oral prednisolone solution or placebo solution) was provided in sequentially numbered bottles. Prednisolone and placebo solutions were identical in appearance, smell, and taste. Patients, outcome assessors (not authors), and data analysts (FPBK and SB) remained masked for treatment allocation until the study database was locked.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prednisolone
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prednisolone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients self-administered 2 mL of 5 mg/mL prednisolone solution (ie, a 10 mg dose)

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    Patients self-administered 2 mL of placebo solution once daily for 6 weeks

    Number of subjects in period 1
    		Prednisolone Placebo
    Started
    46
    46
    Completed
    42
    42
    Not completed
    4
    4
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    1
    3
         elective surgery
    1
    -
         Lack of efficacy
    2
    -

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Prednisolone Placebo Total
    Number of subjects
    		 46 46 92
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.2 ± 8.8 65.6 ± 8.5 -
    Gender categorical
    Units: Subjects
        Female
    		 38 35 73
        Male
    		 8 11 19

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: VAS pain fingers

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    End point title
    		 VAS pain fingers
    End point description
    End point type
    Primary
    End point timeframe
    6 weeks
    End point values
    		 Prednisolone Placebo
    Number of subjects analysed
    46
    46
    Units: 100
        arithmetic mean (standard deviation)
    -21.5 ± 21.7
    -5.2 ± 24.3
    Statistical analysis title
    		 main analysis
    Statistical analysis description
    We analysed all endpoints with generalised estimating equations, and we used robust standard errors and the working correlation structure specified as exchangeable. Data from all available timepoints were used. The independent variables included in our model were treatment group, visit number (categorical), interaction between treatment group and visit number, the baseline value of dependent variable (continuous), and study centre (categorical).
    Comparison groups
    Prednisolone v Placebo
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (net)
    Point estimate
    -16.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.1
         upper limit
    		 -6.9
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 weeks
    Adverse event reporting additional description
    Safety endpoints were the number of adverse events, serious adverse events, withdrawals because of adverse events, and changes in blood glucose concentrations between baseline and week 2.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 none
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Prednisolone
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Prednisolone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 46 (2.17%)
    4 / 46 (8.70%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 46 (2.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    bowel surgery
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    symptomatic uterine myomas requiring hysterectomy
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    infected traumatic leg haematoma requiring surgery
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Prednisolone Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 46 (93.48%)
    43 / 46 (93.48%)
    Cardiac disorders
    Hypertension
         subjects affected / exposed
    0 / 46 (0.00%)
    1 / 46 (2.17%)
         occurrences all number
    0
    1
    Nervous system disorders
    headache dizziness or lightheadedness
         subjects affected / exposed
    7 / 46 (15.22%)
    5 / 46 (10.87%)
         occurrences all number
    7
    5
    General disorders and administration site conditions
    other
         subjects affected / exposed
    8 / 46 (17.39%)
    6 / 46 (13.04%)
         occurrences all number
    8
    6
    Psychiatric disorders
    hyperactivity or sleeping problems
         subjects affected / exposed
    3 / 46 (6.52%)
    0 / 46 (0.00%)
         occurrences all number
    3
    0
    Endocrine disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 46 (2.17%)
    3 / 46 (6.52%)
         occurrences all number
    1
    3
    Musculoskeletal and connective tissue disorders
    musculoskeletal or aspecific aches
         subjects affected / exposed
    3 / 46 (6.52%)
    3 / 46 (6.52%)
         occurrences all number
    3
    3
    Infections and infestations
    all infections
         subjects affected / exposed
    21 / 46 (45.65%)
    25 / 46 (54.35%)
         occurrences all number
    21
    25

    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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