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    Clinical Trial Results:
    Enumeration and Functional Evaluation of Regulatory T-cells in Psoriasis Patients Before and After Treatment with: Calcipotriol/Betamethasone, Acitretin, Narrow-Band UVB and Anti-TNF α Therapy (Etanercept, Adalimumab and Infliximab)

    Summary
    EudraCT number
    		 2010-019129-32
    Trial protocol
    		 GB  
    Global end of trial date
    30 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Aug 2018
    First version publication date
    24 Aug 2018
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    pRGF/009/10
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01233583
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Aberdeen
    Sponsor organisation address
    Research Governance, Foresterhill House Annexe, Aberdeen, United Kingdom,
    Public contact
    Robert N. Baker, University of Aberdeen, 01224 554362, researchgovernance@abdn.ac.uk
    Scientific contact
    Robert N. Barker, University of Aberdeen, 01224 554362, researchgovernance@abdn.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 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) The objective is to test whether patient's response to conventional currently used psoriasis treatment, used in normal clinical practice is determined by regulatory T cells (cells which control the inflammtory response in psoriasis). 2) This will be acheived for each of 4 routinely used types of psoriasis therapy (topical calcipotriol/betamethasone combination, oral retinoid, NBUVB and anti-TNF α therapy) by taking blood tests and a skin sample before treatment and after 6weeks 3) The analysis of samples for Treg and Teffector cells.
    Protection of trial subjects
    This study was approved by the North of Scotland Research Ethics Committee and the Medicines and Healthcare Products Regulatory Agency according to the Declaration of Helsinki protocols. All participants signed written informed consent.
    Background therapy
    		 The imbalance between CD4+ T effector cells, particularly the T helper (Th) 17 sub-set, and regulatory T cells (Tregs) is key to the development of psoriatic lesions, and therefore a novel therapeutic target.
    Evidence for comparator
    		 This study quantifies in patients the effects of three commonly used psoriasis treatment modalities on the TH1, Th2, Th17 and Treg subsets, and tests whether any changes correlate with clinical response.
    Actual start date of recruitment
    24 Jun 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: 34
    Worldwide total number of subjects
    34
    EEA total number of subjects
    34
    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)
    34
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients will be identified and recruited from the department of Dermatology by clinical members of the study team. Posters will be displayed in GP surgeries, the dermatology clinic, on television screens in medical sciences building on the Foresterhill site to speed up the rate of recruitment in Dovobet arm.

    Pre-assignment
    Screening details
    		 Participants who response to the poster and are identified as suitable and interested in taking part will receive the patient information sheet and be notified to the study team who will arrange for the consent to be taken. Patients will receive treatments as part of their routine clinical care.

    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
    Standard routine care

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dovobet
    Arm description
    		 One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
    Arm type
    		 Standard Clinical Treatment

    Investigational medicinal product name
    Calcipottriol/betamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Ointment
    Routes of administration
    Topical use
    Dosage and administration details
    Dovobet ointment should be applied to the affected area once daily.

    Arm title
    		 Adalimumab
    Arm description
    		 Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
    Arm type
    		 Standard Clinical Treatment

    Investigational medicinal product name
    Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20mg solution for injection is pre-filled syringe.

    Arm title
    		 NB-UVB
    Arm description
    		 Narrowband NB-UVB phototherapy
    Arm type
    		 Standard Clinical Treatment

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Dovobet Adalimumab NB-UVB
    Started
    8
    11
    15
    Completed
    8
    11
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 A breakdown of the age groups recruited are not available, only the total recruitment figure.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 34 34
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 34 34
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 23 23

    End points

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    End points reporting groups
    Reporting group title
    Dovobet
    Reporting group description
    		 One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

    Reporting group title
    Adalimumab
    Reporting group description
    		 Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.

    Reporting group title
    NB-UVB
    Reporting group description
    		 Narrowband NB-UVB phototherapy

    Primary: Clinical-immunological correlation

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    End point title
    		 Clinical-immunological correlation
    End point description
    End point type
    Primary
    End point timeframe
    Before and after receiving treatment.
    End point values
    		 Dovobet Adalimumab NB-UVB
    Number of subjects analysed
    8
    11
    15
    Units: Mann-Whitney U-test
    8
    11
    15
    Statistical analysis title
    		 Two-tailed paired t-test
    Statistical analysis description
    Statistical analysis were carried out using Prism GraphPad 5 for windows, V5.02 2008. A two-tailed paired t-test was used to compare proportions of cells in lesional vs nonlesional skin, blood of patients.
    Comparison groups
    Adalimumab v NB-UVB v Dovobet
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Spearman correlation
    Confidence interval
    Notes
    [1] - The Mann-Whitney U-test was used to compare the proportions of cells between blood and skin of patients and healthy controls.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Once the investigator becomes aware that a SAE has occurred in a study participant, they will report it via Yellow Card Scheme to, REC, R&D and to the sponsor as per the University of Aberdeen SOP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 N/A
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: Not documented in final report.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Mar 2012
    AM03 – To extend the study end date; increase the number of participants; additional advertising to increase recruitment in the Dovobet arm.

    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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