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    Clinical Trial Results:
    Evaluation of inflammatory and structural joint damage in patients with psoriasis and psoriatic arthritis treated with secukinumab: A phase 2, single arm, single centre mode of action study (Psoriasis-Arthritis & Bone Program, PSARTROS)

    Summary
    EudraCT number
    		 2014-004798-17
    Trial protocol
    		 DE  
    Global end of trial date
    18 Sep 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2020
    First version publication date
    15 Jul 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2301T
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02483234
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitätsklinikum Erlangen
    Sponsor organisation address
    Maximiliansplatz 2, Erlangen, Germany, 91054
    Public contact
    Medizinische Klinik 3, Universitätsklinikum Erlangen, georg.schett@uk-erlangen.de
    Scientific contact
    Medizinische Klinik 3, Universitätsklinikum Erlangen, georg.schett@uk-erlangen.de
    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
    28 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effect of secukinumab on inflammatory and structural signs and Symptoms (PsAMRIS score)
    Protection of trial subjects
    Routine lab Control, physical examination and AE assessment at regular intervals; discontinuation of Treatment in case of any AE that is not compatible with IMP Administration, life-threatening infections, malignancies, pregnancy or any lab abnormalities that are deemed to place the subject at a safety Risk
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jun 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
    Germany: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    33
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 IC: adequate wash-out time for pretreatment with TNFInhibitors / ustekinumab; PsA subj: moderate to severe PsA with Symptoms for at least 6 months / Psoriasis subj: inflamm. or structural lesions/erosions in MRI/HR-pQCT 48 subj assessed for eligibility, 8 subj excluded, 40 included

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Psoriasis
    Arm description
    		 Subjects with Psoriasis (without PsA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg s.c. week 0,1,2,3,4,8,12,16,20

    Arm title
    		 Psoriasis Arthritis
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg s.c. week 0,1,2,3,4,8,12,16,20

    Number of subjects in period 1
    		Psoriasis Psoriasis Arthritis
    Started
    20
    20
    Completed
    19
    17
    Not completed
    1
    3
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    1
         Lack of efficacy
    1
    1
    Period 2
    Period 2 title
    Analysis period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Psoriasis
    Arm description
    		 Subjects with Psoriasis (without PsA)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg s.c. week 0,1,2,3,4,8,12,16,20

    Arm title
    		 Psoriasis Arthritis
    Arm description
    		 Subjects with PsA
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300mg s.c. week 0,1,2,3,4,8,12,16,20

    Number of subjects in period 2
    		Psoriasis Psoriasis Arthritis
    Started
    19
    17
    Completed
    18
    17
    Not completed
    1
    0
         unable to perform MRI
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Psoriasis
    Reporting group description
    		 Subjects with Psoriasis (without PsA)

    Reporting group title
    Psoriasis Arthritis
    Reporting group description
    		 -

    Reporting group values
    		 Psoriasis Psoriasis Arthritis Total
    Number of subjects
    		 20 20 40
    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
        median (inter-quartile range (Q1-Q3))
    		 49.5 (42.8 to 59) 50.5 (44 to 59) -
    Gender categorical
    Units: Subjects
        Female
    		 6 12 18
        Male
    		 14 8 22
    Pre-treatment with bDMARDs
    Units: Subjects
        positive
    		 0 9 9
        negative
    		 20 11 31
    Concomitant cDMARDs
    Units: Subjects
        positive
    		 0 8 8
        negative
    		 20 12 32
    PDUS synovitis
    Units: Subjects
        positive
    		 0 14 14
        negative
    		 0 6 6
        not recorded
    		 20 0 20
    Disease duration
    Units: year
        median (inter-quartile range (Q1-Q3))
    		 14 (5 to 20) 5.5 (1.25 to 12.75) -
    TJC
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 3.75) 10 (6.25 to 20) -
    SJC
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 0 (0 to 0) 4 (3 to 5.75) -
    PASI
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 6.8 (3.5 to 18.6) 0.4 (0.2 to 1.9) -
    BSA
    Units: percent
        median (inter-quartile range (Q1-Q3))
    		 10.9 (3.6 to 20.3) 0.4 (0.2 to 1.5) -
    total PSAMRIS
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 4 (0.75 to 7.25) 5.5 (3 to 19.5) -
    HR-pQCT erosion number
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 -
    PDSU OMERACT global
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    		 5 (3 to 11) -
    Subject analysis sets

    Subject analysis set title
    Psoriasis PP week 0
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects with Psoriasis receiving Treatment with secukinumab for 24 weeks, PSAMRIS score at week 24 available

    Subject analysis set title
    Psoriasis Arthritis PP week 0
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects with Psoriasis Arthritis receiving Treatment with secukinumab for 24 weeks, PSAMRIS score at week 24 available

    Subject analysis sets values
    		 Psoriasis PP week 0 Psoriasis Arthritis PP week 0
    Number of subjects
    18
    17
    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)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    47 ( to )
    50 ( to )
    Gender categorical
    Units: Subjects
        Female
    5
    1
        Male
    13
    7
    Pre-treatment with bDMARDs
    Units: Subjects
        positive
        negative
    Concomitant cDMARDs
    Units: Subjects
        positive
        negative
    PDUS synovitis
    Units: Subjects
        positive
    12
        negative
    5
        not recorded
    18
    0
    Disease duration
    Units: year
        median (inter-quartile range (Q1-Q3))
    TJC
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 3.75)
    10 (6 to 16.5)
    SJC
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    0 (0 to 0)
    4 (3 to 7)
    PASI
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    6.9 (3.5 to 18.6)
    0.4 (0.2 to 2.3)
    BSA
    Units: percent
        median (inter-quartile range (Q1-Q3))
    9.2 (4.3 to 18.1)
    0.3 (0.2 to 1.5)
    total PSAMRIS
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    4 (0.75 to 7.25)
    6 (3.5 to 18)
    HR-pQCT erosion number
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1 (0 to 1.75)
    2 (0.5 to 4.5)
    PDSU OMERACT global
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    5 (3 to 11)

    End points

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    End points reporting groups
    Reporting group title
    Psoriasis
    Reporting group description
    		 Subjects with Psoriasis (without PsA)

    Reporting group title
    Psoriasis Arthritis
    Reporting group description
    		 -
    Reporting group title
    Psoriasis
    Reporting group description
    		 Subjects with Psoriasis (without PsA)

    Reporting group title
    Psoriasis Arthritis
    Reporting group description
    		 Subjects with PsA

    Subject analysis set title
    Psoriasis PP week 0
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects with Psoriasis receiving Treatment with secukinumab for 24 weeks, PSAMRIS score at week 24 available

    Subject analysis set title
    Psoriasis Arthritis PP week 0
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All subjects with Psoriasis Arthritis receiving Treatment with secukinumab for 24 weeks, PSAMRIS score at week 24 available

    Primary: Change in PSAMRIS score - Psoriasis Arthritis

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    End point title
    		 Change in PSAMRIS score - Psoriasis Arthritis
    End point description
    PSAMRIS score week 24 compared to PSAMRIS score week 0 in PP-subjects with Psoriasis Arthritis
    End point type
    Primary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    4 (1 to 13.5)
    6 (3.5 to 18)
    Statistical analysis title
    		 Change in PSAMRIS score - Psoriasis Arthritis
    Statistical analysis description
    The Wilcoxon signed-rank test for paired comparisons between baseline and week 24 was used.
    Comparison groups
    Psoriasis Arthritis v Psoriasis Arthritis PP week 0
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 wilcoxon signed-rank test
    Confidence interval

    Primary: Change in PSAMRIS score - Psoriasis

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    End point title
    		 Change in PSAMRIS score - Psoriasis
    End point description
    PSAMRIS score week 24 compared to PSAMRIS score week 0 in PP-subjects with Psoriasis
    End point type
    Primary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [1]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    3 (0 to 6)
    5 (1 to 8)
    Notes
    [1] - 1 subject was excluded from all endpoint analyses as Primary endpoint could not be analysed
    Statistical analysis title
    		 Change in PSAMRIS score - Psoriasis
    Statistical analysis description
    The Wilcoxon signed-rank test for paired comparisons between baseline and week 24 was used.
    Comparison groups
    Psoriasis v Psoriasis PP week 0
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.005
    Method
    		 Wilcoxon signed-rank test
    Confidence interval

    Secondary: Change in PASI - Psoriasis Arthritis

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    End point title
    		 Change in PASI - Psoriasis Arthritis
    End point description
    PASI score week 24 compared to PASI score week 0 in PP-subjects with Psoriasis Arthritis
    End point type
    Secondary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    0.1 (0 to 1.3)
    0.4 (0.2 to 2.3)
    No statistical analyses for this end point

    Secondary: ACR20 response - Psoriasis Arthritis

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    End point title
    		 ACR20 response - Psoriasis Arthritis
    End point description
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Psoriasis Arthritis
    Number of subjects analysed
    17
    Units: subjects
    14
    No statistical analyses for this end point

    Secondary: Change in DAS28-ESR - Psoriasis Arthritis

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    End point title
    		 Change in DAS28-ESR - Psoriasis Arthritis
    End point description
    DAS28-ESR score week 24 compared to DAS28-ESR score week 0 in PP-subjects with Psoriasis Arthritis
    End point type
    Secondary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    2.93 (2.01 to 3.70)
    4.93 (4.08 to 5.74)
    No statistical analyses for this end point

    Secondary: Change in PSAID - Psoriasis

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    End point title
    		 Change in PSAID - Psoriasis
    End point description
    PSAID score week 24 compared to PSAID score week 0 in PP-subjects with Psoriasis
    End point type
    Secondary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [2]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1.35 (0.2 to 2.35)
    3.5 (1.65 to 4.7)
    Notes
    [2] - 1 subject was excluded from all endpoint analyses as Primary endpoint could not be analysed
    No statistical analyses for this end point

    Secondary: Change in DLQI - Psoriasis

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    End point title
    		 Change in DLQI - Psoriasis
    End point description
    DLQI score week 24 compared to DLQI score week 0 in PP-subjects with Psoriasis
    End point type
    Secondary
    End point timeframe
    week 0 to week 24
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [3]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1.5 (0.75 to 5.75)
    10 (5 to 15)
    Notes
    [3] - 1 subject was excluded from all endpoint analyses as Primary endpoint could not be analysed
    No statistical analyses for this end point

    Secondary: Change in PDUS OMERACT global - Psoriasis Arthritis

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    End point title
    		 Change in PDUS OMERACT global - Psoriasis Arthritis
    End point description
    PDUS OMERACT global week 24 compared to PDUS OMERACT global week 0 in PP-subjects with Psoriasis Arthritis
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1 (0 to 5)
    5 (3 to 11)
    No statistical analyses for this end point

    Secondary: Change in HR-pQCT enthesiophytes - Psoriasis Arthritis

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    End point title
    		 Change in HR-pQCT enthesiophytes - Psoriasis Arthritis
    End point description
    HR-pQCT enthesiophytes week 24 compared to HR-pQCT enthesiophytes week 0 in PP-subjects with Psoriasis Arthritis, proliferation grading: grade 0 = absent; grade 1 = maximum heigth <= 4mm; grade 2 = maximum height > 4mm; grade 3 = diffuse osteoproliferation
    End point type
    Secondary
    End point timeframe
    week 24
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    2 (1.5 to 2)
    2 (1 to 2)
    No statistical analyses for this end point

    Secondary: Change in HR-pQCT erosion number - Psoriasis Arthritis

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    End point title
    		 Change in HR-pQCT erosion number - Psoriasis Arthritis
    End point description
    Change in HR-pQCT Erosion number week 24 compared to HR-pQCT erolsion number week 0 in PP-subjects with Psoriasis Arthritis
    End point type
    Secondary
    End point timeframe
    week 24 compared to week 0
    End point values
    		 Psoriasis Arthritis Psoriasis Arthritis PP week 0
    Number of subjects analysed
    17
    17
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    2 (1 to 4)
    2 (0.5 to 4.5)
    No statistical analyses for this end point

    Secondary: Change in PASI - Psoriasis

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    End point title
    		 Change in PASI - Psoriasis
    End point description
    PASI score week 24 compared to PASI score week 0 in PP-subjects with Psoriasis
    End point type
    Secondary
    End point timeframe
    week 24 compared to week 0
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [4]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    0.4 (0 to 1.5)
    6.9 (3.5 to 18.6)
    Notes
    [4] - 1 subject was excluded from analysis as no Primary endpoint available
    No statistical analyses for this end point

    Secondary: Change in HR-pQCT enthesiophytes - Psoriasis

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    End point title
    		 Change in HR-pQCT enthesiophytes - Psoriasis
    End point description
    HR-pQCT enthesiophytes week 24 compared to HR-pQCT enthesiophytes week 0 in PP-subjects with Psoriasis
    End point type
    Secondary
    End point timeframe
    week 24 compared to week 0
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [5]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1 (0 to 1.75)
    1 (0 to 1.75)
    Notes
    [5] - 1 subject was excluded from endpoint analyses as no Primary endpoint was available
    No statistical analyses for this end point

    Secondary: Change in HR-pQCT erosion number - Psoriasis

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    End point title
    		 Change in HR-pQCT erosion number - Psoriasis
    End point description
    Change in HR-pQCT Erosion number week 24 compared to HR-pQCT erolsion number week 0 in PP-subjects with Psoriasis
    End point type
    Secondary
    End point timeframe
    week 24 compared to week 0
    End point values
    		 Psoriasis Psoriasis PP week 0
    Number of subjects analysed
    18 [6]
    18
    Units: unit(s)
        median (inter-quartile range (Q1-Q3))
    1 (0 to 1.75)
    1 (0 to 1.75)
    Notes
    [6] - 1 subject was excluded from all endpoint analyses as Primary endpoint was not available
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of enrolment (signature informed consent) until EoS visit (week 24)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    All subjects
    Reporting group description
    		 Subjects with PsA or Psoriasis

    Serious adverse events
    		 All subjects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All subjects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    39 / 40 (97.50%)
    Investigations
    Liver function test increased
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Injection site haematoma
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    7
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Arthralgia
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    15 / 40 (37.50%)
         occurrences all number
    21
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Sinusitis
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Genital infection fungal
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Oral herpes
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    4
    Nail infection
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Vitamin D deficiency
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 May 2015
    Protocol v2.0

    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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