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    Clinical Trial Results:
    A prospective, single-centre, feasibility study evaluating the prevalence of diagnostic clinical imaging features of subclinical enthesitis in patients with moderate to severe plaque psoriasis and the response to skin directed treatment with Ustekinumab

    Summary
    EudraCT number
    		 2012-002640-25
    Trial protocol
    		 GB  
    Global end of trial date
    26 Oct 2016

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

    Trial information

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    Trial identification
    Sponsor protocol code
    RR12/10234
    Additional study identifiers
    ISRCTN number
    		 ISRCTN18043449
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor Number: RR12/10234
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Clarendon way, Leeds, United Kingdom, LS2 9JT
    Public contact
    Academic Unit of MSK Disease, University of Leeds Institute of Molecular Medicine (Section of Musculoskeletal Disease), 44 07817407699, D.G.McGonagle@leeds.ac.uk
    Scientific contact
    Academic Unit of MSK Disease, University of Leeds Institute of Molecular Medicine (Section of Musculoskeletal Disease), 44 07817407699, D.G.McGonagle@leeds.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 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Do the imaging features of subclinical enthesopathy (the earliest change seen in psoriatic arthritis), as measured by peripheral joint ultrasound (USS) and whole body MRI, in patients with moderate-to-severe psoriasis (PASI>10), change when treated for 24 weeks with ustekinumab (at standard dose) for their psoriatic skin disease?
    Protection of trial subjects
    All trial subjects were protected as Per University of Leeds Indemnity. All members of the trial team are appropriately GCP trained and have experience within their research fields.
    Background therapy
    		 All treatments being taken (prescribed or otherwise) taken by participants on entry to the study or at any time during the study, in addition to the investigational product are regarded as concomitant treatments and will be documented. Concomitant medications should be kept to a minimum during the study. However, if these are considered necessary for the participants’ welfare, and are unlikely to interfere with the investigational products, they may be permitted at the discretion of the investigator and recorded. Permitted concomitant medications • Topical psoriasis therapies, including: o Emollients o Vitamin D analogues o Topical corticosteroids o Coal tar preparations o Dithranol o Tazarotene o Eosin • Analgesic medications, including paracetamol, codeine, tramadol and morphine. PRN use of NSAID medications is permitted as long as it is NOT excess of two standard doses (e.g. ibuprofen 400mg) per week.
    Evidence for comparator
    		 This is a single arm, open label feasibility study, with no comparator.
    Actual start date of recruitment
    01 Jan 2013
    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: 23
    Worldwide total number of subjects
    23
    EEA total number of subjects
    23
    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)
    22
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment opened 01.01.2013. Patients were recruited between the dates of 19.07.2013 and 20.10.2014.

    Pre-assignment
    Screening details
    		 Males & females, aged >18, with plaque psoriasis, naive to systemic or biologic therapy, with certain characteristics: Moderate/severe severity chronic plaque psoriasis (PASI >10) with disease duration of >=12 months. No symptoms of PsA (no EMS>15mins, no joint swelling, no CASPAR or Moll & Wright criteria) Presence of subclinical USS enthesitis

    Period 1
    Period 1 title
    Main trial
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ustekinumab
    Arm description
    		 Patients administered ustekinumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    Other name
    Stelara
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45mg solution for Injection in pre filled syringe

    Number of subjects in period 1
    		ustekinumab
    Started
    23
    Completed
    23
    Period 2
    Period 2 title
    Week 52 extension (optional)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 ustekinumab
    Arm description
    		 Patients administered ustekinumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    ustekinumab
    Investigational medicinal product code
    Other name
    Stelara
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    45mg solution for Injection in pre filled syringe

    Number of subjects in period 2 [1]
    		ustekinumab
    Started
    20
    Completed
    20
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: this phase was optional and not all patients opted to continue to this extended period of follow-up

    Baseline characteristics

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

    Reporting group values
    		 Main trial Total
    Number of subjects
    		 23 23
    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)
    		 22 22
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 45 (33 to 55) -
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 12 12
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set includes all patients who were recruited to receive Ustekinumab, irrespective of subsequent treatment status

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    23
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
    22
        From 65-84 years
    1
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    45 (33 to 55)
    Gender categorical
    Units: Subjects
        Female
    11
        Male
    12

    End points

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    End points reporting groups
    Reporting group title
    ustekinumab
    Reporting group description
    		 Patients administered ustekinumab
    Reporting group title
    ustekinumab
    Reporting group description
    		 Patients administered ustekinumab

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    This set includes all patients who were recruited to receive Ustekinumab, irrespective of subsequent treatment status

    Primary: US Total enthesitis score 24

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    End point title
    		 US Total enthesitis score 24
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    14.8 ± 10.6
    14.8 ± 10.6
    Statistical analysis title
    		 US Total enthesitis score 24
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.034
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.7
         upper limit
    		 -0.2
    Variability estimate
    Standard deviation
    Dispersion value
    6.3
    Notes
    [1] - Exploratory superiority

    Primary: US Inflammation enthesitis score 24

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    End point title
    		 US Inflammation enthesitis score 24
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    5.7 ± 5.3
    5.7 ± 5.3
    Statistical analysis title
    		 US Inflammation enthesitis score 24
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.001
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.3
         upper limit
    		 -2.1
    Variability estimate
    Standard deviation
    Dispersion value
    4.9
    Notes
    [2] - Exploratory superiority

    Primary: US Chronic enthesitis score 24

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    End point title
    		 US Chronic enthesitis score 24
    End point description
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    9.1 ± 6.5
    9.1 ± 6.5
    Statistical analysis title
    		 US Chronic enthesitis score 24
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.082
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 2.7
    Variability estimate
    Standard deviation
    Dispersion value
    3.3
    Notes
    [3] - Exploratory analysis of within-group change from baseline for single arm study

    Secondary: US Total enthesitis score 12

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    End point title
    		 US Total enthesitis score 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    13.8 ± 9.1
    13.8 ± 9.1
    Statistical analysis title
    		 US Total enthesitis score 12
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 other [4]
    P-value
    		 = 0.001
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 -1.9
    Variability estimate
    Standard deviation
    Dispersion value
    4.7
    Notes
    [4] - Exploratory superiority

    Secondary: US Total enthesitis score 52

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    End point title
    		 US Total enthesitis score 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [5]
    Units: AU
        arithmetic mean (standard deviation)
    13.6 ± 9.9
    13.6 ± 9.9
    Notes
    [5] - Three patients in the full analysis set did not complete the optional week 52 assessment
    Statistical analysis title
    		 US Total enthesitis score 52
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 other [6]
    P-value
    		 = 0.047
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 -0.1
    Variability estimate
    Standard deviation
    Dispersion value
    8.3
    Notes
    [6] - Exploratory superiority

    Secondary: US Inflammation enthesitis score 12

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    End point title
    		 US Inflammation enthesitis score 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    6.8 ± 4.9
    6.8 ± 4.9
    Statistical analysis title
    		 US Inflammation enthesitis score 24
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 other [7]
    P-value
    		 = 0.001
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 -1.5
    Variability estimate
    Standard deviation
    Dispersion value
    3.8
    Notes
    [7] - Exploratory superiority

    Secondary: US Inflammation enthesitis score 52

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    End point title
    		 US Inflammation enthesitis score 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [8]
    Units: AU
        arithmetic mean (standard deviation)
    4.8 ± 4.6
    4.8 ± 4.6
    Notes
    [8] - Three patients in the full analysis set did not complete the optional week 52 assessment
    Statistical analysis title
    		 US Inflammation enthesitis score 52
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 other [9]
    P-value
    		 = 0.001
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.1
         upper limit
    		 -2.3
    Variability estimate
    Standard deviation
    Dispersion value
    5.2
    Notes
    [9] - Exploratory superiority

    Secondary: US Chronic enthesitis score 12

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    End point title
    		 US Chronic enthesitis score 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    7.0 ± 5.7
    7.0 ± 5.7
    Statistical analysis title
    		 US Chronic enthesitis score 12
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    46
    Analysis specification
    Post-hoc
    Analysis type
    		 other [10]
    P-value
    		 = 0.137
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 0.3
    Variability estimate
    Standard deviation
    Dispersion value
    2.6
    Notes
    [10] - Exploratory superiority

    Secondary: US Chronic enthesitis score 52

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    End point title
    		 US Chronic enthesitis score 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [11]
    Units: AU
        arithmetic mean (standard deviation)
    8.6 ± 7.0
    8.6 ± 7.0
    Notes
    [11] - Three patients in the full analysis set did not complete the optional week 52 assessment
    Statistical analysis title
    		 US Chronic enthesitis score 52
    Comparison groups
    ustekinumab v Full analysis set
    Number of subjects included in analysis
    40
    Analysis specification
    Post-hoc
    Analysis type
    		 other [12]
    P-value
    		 = 0.512
    Method
    		 Paired Student's t-test
    Parameter type
    		 Change from baseline
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 3.1
    Variability estimate
    Standard deviation
    Dispersion value
    5
    Notes
    [12] - Exploratory superiority

    Secondary: MRI BMO Peripheral Skeleton 24

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    End point title
    		 MRI BMO Peripheral Skeleton 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    2.30 ± 2.40
    2.30 ± 2.40
    No statistical analyses for this end point

    Secondary: MRI BMO Peripheral Skeleton 52

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    End point title
    		 MRI BMO Peripheral Skeleton 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [13]
    Units: AU
        arithmetic mean (standard deviation)
    2.55 ± 2.80
    2.55 ± 2.80
    Notes
    [13] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI Bursitis Peripheral Skeleton 24

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    End point title
    		 MRI Bursitis Peripheral Skeleton 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    2.26 ± 1.71
    2.26 ± 1.71
    No statistical analyses for this end point

    Secondary: MRI Bursitis Peripheral Skeleton 52

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    End point title
    		 MRI Bursitis Peripheral Skeleton 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [14]
    Units: AU
        arithmetic mean (standard deviation)
    2.20 ± 1.82
    2.20 ± 1.82
    Notes
    [14] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI Synovitis Peripheral Skeleton 24

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    End point title
    		 MRI Synovitis Peripheral Skeleton 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    3.39 ± 1.88
    3.39 ± 1.88
    No statistical analyses for this end point

    Secondary: MRI Synovitis Peripheral Skeleton 52

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    End point title
    		 MRI Synovitis Peripheral Skeleton 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [15]
    Units: AU
        arithmetic mean (standard deviation)
    3.30 ± 1.92
    3.30 ± 1.92
    Notes
    [15] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI Tenosynovitis/Enthesitis Peripheral Skeleton 24

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    End point title
    		 MRI Tenosynovitis/Enthesitis Peripheral Skeleton 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    0.17 ± 0.58
    0.17 ± 0.58
    No statistical analyses for this end point

    Secondary: MRI Tenosynovitis/Enthesitis Peripheral Skeleton 52

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    End point title
    		 MRI Tenosynovitis/Enthesitis Peripheral Skeleton 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [16]
    Units: AU
        arithmetic mean (standard deviation)
    0.25 ± 0.64
    0.25 ± 0.64
    Notes
    [16] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI BMO Spine 24

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    End point title
    		 MRI BMO Spine 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    1.91 ± 2.64
    1.91 ± 2.64
    No statistical analyses for this end point

    Secondary: MRI BMO Spine 52

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    End point title
    		 MRI BMO Spine 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [17]
    Units: AU
        arithmetic mean (standard deviation)
    1.55 ± 2.01
    1.55 ± 2.01
    Notes
    [17] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI Fatty Infiltration Spine 24

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    End point title
    		 MRI Fatty Infiltration Spine 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    0.39 ± 1.12
    0.39 ± 1.12
    No statistical analyses for this end point

    Secondary: MRI Fatty Infiltration Spine 52

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    End point title
    		 MRI Fatty Infiltration Spine 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [18]
    Units: AU
        arithmetic mean (standard deviation)
    0.40 ± 1.89
    0.40 ± 1.89
    Notes
    [18] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI BMO Sacroiliac Joints 24

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    End point title
    		 MRI BMO Sacroiliac Joints 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    0.30 ± 0.88
    0.30 ± 0.88
    No statistical analyses for this end point

    Secondary: MRI BMO Sacroiliac Joints 52

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    End point title
    		 MRI BMO Sacroiliac Joints 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [19]
    Units: AU
        arithmetic mean (standard deviation)
    0.10 ± 0.31
    0.10 ± 0.31
    Notes
    [19] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MRI Erosions Sacroiliac Joints 24

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    End point title
    		 MRI Erosions Sacroiliac Joints 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        arithmetic mean (standard deviation)
    0.09 ± 0.42
    0.09 ± 0.42
    No statistical analyses for this end point

    Secondary: MRI Erosions Sacroiliac Joints 52

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    End point title
    		 MRI Erosions Sacroiliac Joints 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [20]
    Units: AU
        arithmetic mean (standard deviation)
    0.09 ± 0.42
    0.09 ± 0.42
    Notes
    [20] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: PASI 12

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    End point title
    		 PASI 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    2.3 (0.9 to 3.9)
    2.3 (0.9 to 3.9)
    No statistical analyses for this end point

    Secondary: PASI 24

    		 Close Top of page
    End point title
    		 PASI 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.6 (0.0 to 2.5)
    0.6 (0.0 to 2.5)
    No statistical analyses for this end point

    Secondary: PASI 52

    		 Close Top of page
    End point title
    		 PASI 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [21]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.1 (0.0 to 2.9)
    0.1 (0.0 to 2.9)
    Notes
    [21] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: BSA 12

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    End point title
    		 BSA 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: percent
        median (inter-quartile range (Q1-Q3))
    5.0 (1.0 to 10.0)
    5.0 (1.0 to 10.0)
    No statistical analyses for this end point

    Secondary: BSA 24

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    End point title
    		 BSA 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: percent
        median (inter-quartile range (Q1-Q3))
    1.0 (0.0 to 3.0)
    1.0 (0.0 to 3.0)
    No statistical analyses for this end point

    Secondary: BSA 52

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    End point title
    		 BSA 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [22]
    Units: percent
        median (inter-quartile range (Q1-Q3))
    0.5 (0.0 to 2.75)
    0.5 (0.0 to 2.75)
    Notes
    [22] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: mNAPSI 12

    		 Close Top of page
    End point title
    		 mNAPSI 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    3.0 (0.0 to 16.0)
    3.0 (0.0 to 16.0)
    No statistical analyses for this end point

    Secondary: mNAPSI 24

    		 Close Top of page
    End point title
    		 mNAPSI 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 9.0)
    0.0 (0.0 to 9.0)
    No statistical analyses for this end point

    Secondary: mNAPSI 52

    		 Close Top of page
    End point title
    		 mNAPSI 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [23]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    3.5 (0.0 to 6.75)
    3.5 (0.0 to 6.75)
    Notes
    [23] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: DLQI 12

    		 Close Top of page
    End point title
    		 DLQI 12
    End point description
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.0 (0.0 to 6.0)
    1.0 (0.0 to 6.0)
    No statistical analyses for this end point

    Secondary: DLQI 24

    		 Close Top of page
    End point title
    		 DLQI 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: DLQI 52

    		 Close Top of page
    End point title
    		 DLQI 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    19 [24]
    19 [25]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 3.0)
    0.0 (0.0 to 3.0)
    Notes
    [24] - One patient did not complete the DLQI at week 52
    [25] - Three patients in the full analysis set did not complete the optional week 52 assessment, 1 missing
    No statistical analyses for this end point

    Secondary: HB 24

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    End point title
    		 HB 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    146 (140 to 154)
    146 (140 to 154)
    No statistical analyses for this end point

    Secondary: HB 52

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    End point title
    		 HB 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [26]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    146 (139.5 to 155.25)
    146 (139.5 to 155.25)
    Notes
    [26] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: MCV 24

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    End point title
    		 MCV 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    93.0 (90.0 to 98.0)
    93.0 (90.0 to 98.0)
    No statistical analyses for this end point

    Secondary: MCV 52

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    End point title
    		 MCV 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [27]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    94.0 (90.25 to 99.5)
    94.0 (90.25 to 99.5)
    Notes
    [27] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Platelets 24

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    End point title
    		 Platelets 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    308.0 (249.0 to 342.0)
    308.0 (249.0 to 342.0)
    No statistical analyses for this end point

    Secondary: Platelets 52

    		 Close Top of page
    End point title
    		 Platelets 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [28]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    289.0 (242.0 to 355.5)
    289.0 (242.0 to 355.5)
    Notes
    [28] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: WCC 24

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    End point title
    		 WCC 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    6.77 (5.64 to 7.49)
    6.77 (5.64 to 7.49)
    No statistical analyses for this end point

    Secondary: WCC 52

    		 Close Top of page
    End point title
    		 WCC 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [29]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    6.70 (6.10 to 7.76)
    6.70 (6.10 to 7.76)
    Notes
    [29] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Neutrophils 24

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    End point title
    		 Neutrophils 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    3.78 (3.28 to 4.54)
    3.78 (3.28 to 4.54)
    No statistical analyses for this end point

    Secondary: Neutrophils 52

    		 Close Top of page
    End point title
    		 Neutrophils 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [30]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    3.65 (3.38 to 4.56)
    3.65 (3.38 to 4.56)
    Notes
    [30] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Lymphocytes 24

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    End point title
    		 Lymphocytes 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.99 (1.53 to 2.56)
    1.99 (1.53 to 2.56)
    No statistical analyses for this end point

    Secondary: Lymphocytes 52

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    End point title
    		 Lymphocytes 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [31]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.75 (1.40 to 2.41)
    1.75 (1.40 to 2.41)
    Notes
    [31] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: CRP 24

    		 Close Top of page
    End point title
    		 CRP 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.00 (0.00 to 0.00)
    0.00 (0.00 to 0.00)
    No statistical analyses for this end point

    Secondary: CRP 52

    		 Close Top of page
    End point title
    		 CRP 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [32]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    0.00 (0.00 to 0.00)
    0.00 (0.00 to 0.00)
    Notes
    [32] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: PV 24

    		 Close Top of page
    End point title
    		 PV 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.64 (1.57 to 1.68)
    1.64 (1.57 to 1.68)
    No statistical analyses for this end point

    Secondary: PV 52

    		 Close Top of page
    End point title
    		 PV 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [33]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.66 (1.60 to 1.71)
    1.66 (1.60 to 1.71)
    Notes
    [33] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Urea 24

    		 Close Top of page
    End point title
    		 Urea 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    5.40 (4.40 to 6.30)
    5.40 (4.40 to 6.30)
    No statistical analyses for this end point

    Secondary: Urea 52

    		 Close Top of page
    End point title
    		 Urea 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [34]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    4.95 (4.43 to 5.55)
    4.95 (4.43 to 5.55)
    Notes
    [34] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Creatinine 24

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    End point title
    		 Creatinine 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    67.00 (55.00 to 77.00)
    67.00 (55.00 to 77.00)
    No statistical analyses for this end point

    Secondary: Creatinine 52

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    End point title
    		 Creatinine 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [35]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    72.50 (57.75 to 81.25)
    72.50 (57.75 to 81.25)
    Notes
    [35] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Na 24

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    End point title
    		 Na 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    140.00 (140.00 to 141.00)
    140.00 (140.00 to 141.00)
    No statistical analyses for this end point

    Secondary: Na 52

    		 Close Top of page
    End point title
    		 Na 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [36]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    140.00 (138.25 to 141.00)
    140.00 (138.25 to 141.00)
    Notes
    [36] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: K 24

    		 Close Top of page
    End point title
    		 K 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    4.40 (4.10 to 4.60)
    4.40 (4.10 to 4.60)
    No statistical analyses for this end point

    Secondary: K 52

    		 Close Top of page
    End point title
    		 K 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [37]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    4.35 (4.10 to 4.60)
    4.35 (4.10 to 4.60)
    Notes
    [37] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: ALT 24

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    End point title
    		 ALT 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    26.00 (23.00 to 36.00)
    26.00 (23.00 to 36.00)
    No statistical analyses for this end point

    Secondary: ALT 52

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    End point title
    		 ALT 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [38]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    27.00 (18.50 to 39.25)
    27.00 (18.50 to 39.25)
    Notes
    [38] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Bilirubin 24

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    End point title
    		 Bilirubin 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    8.00 (5.00 to 12.00)
    8.00 (5.00 to 12.00)
    No statistical analyses for this end point

    Secondary: Bilirubin 52

    		 Close Top of page
    End point title
    		 Bilirubin 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [39]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    11.00 (8.00 to 15.00)
    11.00 (8.00 to 15.00)
    Notes
    [39] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: ALP 24

    		 Close Top of page
    End point title
    		 ALP 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    170.00 (140.00 to 208.00)
    170.00 (140.00 to 208.00)
    No statistical analyses for this end point

    Secondary: ALP 52

    		 Close Top of page
    End point title
    		 ALP 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [40]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    173.00 (127.25 to 207.25)
    173.00 (127.25 to 207.25)
    Notes
    [40] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Albumin 24

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    End point title
    		 Albumin 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    45.00 (44.00 to 47.00)
    45.00 (44.00 to 47.00)
    No statistical analyses for this end point

    Secondary: Albumin 52

    		 Close Top of page
    End point title
    		 Albumin 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [41]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    45.00 (42.25 to 45.75)
    45.00 (42.25 to 45.75)
    Notes
    [41] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: ANA 24

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    End point title
    		 ANA 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: Positive
    0
    0
    No statistical analyses for this end point

    Secondary: ANA 52

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    End point title
    		 ANA 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [42]
    Units: Positive
    0
    0
    Notes
    [42] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: HDL cholesterol 24

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    End point title
    		 HDL cholesterol 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.50 (1.20 to 1.75)
    1.50 (1.20 to 1.75)
    No statistical analyses for this end point

    Secondary: HDL cholesterol 52

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    End point title
    		 HDL cholesterol 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [43]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.35 (1.20 to 1.80)
    1.35 (1.20 to 1.80)
    Notes
    [43] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: LDL cholesterol 24

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    End point title
    		 LDL cholesterol 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    2.60 (2.45 to 3.70)
    2.60 (2.45 to 3.70)
    No statistical analyses for this end point

    Secondary: LDL cholesterol 52

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    End point title
    		 LDL cholesterol 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [44]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    2.65 (2.30 to 4.00)
    2.65 (2.30 to 4.00)
    Notes
    [44] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Triglycerides 24

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    End point title
    		 Triglycerides 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.50 (0.90 to 2.15)
    1.50 (0.90 to 2.15)
    No statistical analyses for this end point

    Secondary: Triglycerides 52

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    End point title
    		 Triglycerides 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [45]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    1.30 (0.85 to 2.10)
    1.30 (0.85 to 2.10)
    Notes
    [45] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Secondary: Glucose 24

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    End point title
    		 Glucose 24
    End point description
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    23
    23
    Units: AU
        median (inter-quartile range (Q1-Q3))
    4.80 (4.50 to 5.65)
    4.80 (4.50 to 5.65)
    No statistical analyses for this end point

    Secondary: Glucose 52

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    End point title
    		 Glucose 52
    End point description
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 ustekinumab Full analysis set
    Number of subjects analysed
    20
    20 [46]
    Units: AU
        median (inter-quartile range (Q1-Q3))
    5.00 (4.70 to 6.65)
    5.00 (4.70 to 6.65)
    Notes
    [46] - Three patients in the full analysis set did not complete the optional week 52 assessment
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs will be collected from the signing of the informed consent form to 30 days after the end of a patient’s participation in the trial (the last study visit at week 24 or early discontinuation visit).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    ustekinumab
    Reporting group description
    		 Patients administered ustekinumab

    Serious adverse events
    		 ustekinumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 23 (8.70%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Fracture
    Additional description: One patient was involved in a road traffic accident while riding her scooter just before her week 16 visit and sustained a severe fracture of her left femur. She underwent surgical pinning and was hospitalised for several weeks. Not attributed to IMP
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abscess intestinal
    Additional description: Another patient developed an abdominal pericolic gutter abscess at week 37 of treatment (last investigational dose was week 16). Required hospitalisation + IV antibiotics for 7 days, but recovered. Possibly UST related but treatment continued.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ustekinumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 23 (86.96%)
    Investigations
    Anaemia
    Additional description: One patient was found to be anaemic at week 16 and was referred back to GP for further investigation (OGD, colonoscopy and CT); they later received an iron infusion.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Soft tissue injury
    Additional description: One patient sustained accidental trauma to the left shoulder at the gymnasium around week 2 and chose to wear a sling for a couple of weeks but did not seek medical advice. He was symptom free and had a full ROM at his next review at week 4
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Fracture
    Additional description: At week 16 one patient had a possible fracture in their 2nd toe on their right foot, but this required no surgery or treatment.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    4 / 23 (17.39%)
         occurrences all number
    4
    Gastrointestinal disorders
    Gastroenteritis
    Additional description: Developed around week 22. This was self-limiting and did not require any treatment other than rest and oral hydration.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Dyspepsia
    Additional description: At the 52 week visit (during the optional extension phase during which UST was administered under standard of care) one patient reported dyspepsia four days after the last dose of UST; however, a prick test was negative.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    Additional description: At the 52 week visit (during the optional extension phase during which UST was administered under standard of care) one patient reported shortness of breath four days after the last dose of UST; however, a prick test was negative.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
    Additional description: One patient developed facial acne for which a topical retinoid/benzoyl peroxide product was prescribed
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Folliculitis
    Additional description: One patient developed small areas of folliculitis on the abdominal wall, away from the injection site, which resolved without treatment
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Rash
    Additional description: At the week 24 visit, one patient was found to have erythema and bran-like scale in both gaiter areas, more right side than left, more lateral than medial, with ill-defined margins.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Renal and urinary disorders
    Hypertension
    Additional description: At week 16 it was reported that another patient had developed hypertension and had seen a cardiologist for tests. They were given a heart monitor and a renal ultrasound was arranged. Their candesartan dose was increased.
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Infections and infestations
    Upper respiratory tract infection
    Additional description: Five patients developed an upper respiratory tract infection (1 at week 4, 4 around week 12) for which they consulted with their General Practitioner, for which two received a short course of oral antibiotics.
         subjects affected / exposed
    5 / 23 (21.74%)
         occurrences all number
    5
    Tooth abscess
    Additional description: One patient reported a tooth abscess at week 4
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1
    Nail infection
    Additional description: One patient had a fungal nail infection on their great toe at the 52 week visit (during the optional extension phase during which UST was administered under standard of care).
         subjects affected / exposed
    1 / 23 (4.35%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2013
    Protocol amended to v2.0. Addition of a control group to the trial consisting of psoriasis patients attending for NBUVB phototherapy. TO undergo US on peripheral joints and whole body MRI. Associated documentation also added to the trial including consent form, PIS and GP leaflet for the above patient group.
    27 Oct 2014
    Protocol amended to v3.0. Study extension, and the addition of a healthy control group to undergo a one off ultrasound & whole body MRI for analysis.

    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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