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    Clinical Trial Results:
    BOSTRIP (Investigator Initiated Trial) (Biomarkers of systemic treatment response in Psoriasis) Differential analysis of metabolomic profiles in patients with chronic plaque psoriasis undergoing systemic treatment

    Summary
    EudraCT number
    		 2011-000815-15
    Trial protocol
    		 DE  
    Global end of trial date
    19 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 May 2020
    First version publication date
    31 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BOS-1168-WEI-0080-I
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01403012
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Technische Universität München, Fakultät für Medizin
    Sponsor organisation address
    Ismaninger Str. 22, München, Germany, 81675
    Public contact
    Department of Dermatology and Allergy, Technische Universität München Biedersteiner Str. 29, Technische Universität München, Fakultät für Medizin, 89 4140 3396,
    Scientific contact
    Department of Dermatology and Allergy, Technische Universität München Biedersteiner Str. 29, Technische Universität München, Fakultät für Medizin, 89 4140 3396,
    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
    04 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary aim of this study was to analyze metabolic profiles of patients with chronic plaque psoriasis as compared to healthy controls, and the effects of systemic treatment with TNFα-inhibitors (etanercept, adalimumab, infliximab) and fumaric acid esters (FAE) in order to identify clinical and metabolomic markers that underlie variability in response to therapy.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance the ethical principles of Good Clinical Practice (GCP). Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. The study was regularly monitored by the Sponsor and all investigators connected to the study were GCP trained.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Aug 2011
    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: 54
    Worldwide total number of subjects
    54
    EEA total number of subjects
    54
    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)
    54
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 3 centers in in Germany between 18 August 2011 (first patient recruited) and 19 November 2014 (last patient completed).

    Pre-assignment
    Screening details
    		 No Information available.

    Period 1
    Period 1 title
    Pre-Treatment-Phase and Treatment-Phase (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fumaric acid esther
    Arm description
    		 12 weeks of treatment with fumaric acid esther (Fumarderm® p.o.).
    Arm type
    		 observational

    Investigational medicinal product name
    Fumaderm
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gastro-resistant tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The Treatment were administered according to national Guidelines.

    Arm title
    		 TNF-alpha-inhibitors
    Arm description
    		 12 weeks of Treatment with TNFα-Inhibitors.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Enbrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/skin-prick test
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The Treatment were administered according to national Guidelines.

    Investigational medicinal product name
    Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    The Treatment were administered according to national Guidelines.

    Investigational medicinal product name
    Remicade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    The Treatment were administered according to national Guidelines.

    Number of subjects in period 1
    		Fumaric acid esther TNF-alpha-inhibitors
    Started
    31
    23
    Completed
    19
    21
    Not completed
    12
    2
         Lost to follow-up
    12
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fumaric acid esther
    Reporting group description
    		 12 weeks of treatment with fumaric acid esther (Fumarderm® p.o.).

    Reporting group title
    TNF-alpha-inhibitors
    Reporting group description
    		 12 weeks of Treatment with TNFα-Inhibitors.

    Reporting group values
    		 Fumaric acid esther TNF-alpha-inhibitors Total
    Number of subjects
    		 31 23 54
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.5 ( 15.3 ) 48.0 ( 14.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 14 11 25
        Male
    		 17 12 29
    Psoriatic Arthritis
    Units: Subjects
        Psoriatic arthritis
    		 2 4 6
        No psoriatic arthritis
    		 29 19 48
    Mean body height
    Units: cm
        arithmetic mean (standard deviation)
    		 174 ( 6.5 ) 173 ( 13.0 ) -
    Mean body weight
    Units: kg
        arithmetic mean (standard deviation)
    		 84.8 ( 24.1 ) 86.2 ( 20.5 ) -
    Mean BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 27.9 ( 7.5 ) 28.6 ( 5.2 ) -
    PASI score at inclusion
    Patients achieving a PASI (Psoriasis Area and Severity Index) reduction of at least 75% at visit 2 were classified as responder. For further refinement patients were classified into 3 groups with respect to their PASI reduction: no satisfactory response (PASI increased or reduction < 50%), intermediate response (50-75%), good respose (PASI reduction ≥ 75%).
    Units: SCORE
        arithmetic mean (standard deviation)
    		 14.16 ( 0.40 ) 15.23 ( 0.62 ) -

    End points

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    End points reporting groups
    Reporting group title
    Fumaric acid esther
    Reporting group description
    		 12 weeks of treatment with fumaric acid esther (Fumarderm® p.o.).

    Reporting group title
    TNF-alpha-inhibitors
    Reporting group description
    		 12 weeks of Treatment with TNFα-Inhibitors.

    Subject analysis set title
    Responder within Fumaric acid esther
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients achieving a PASI reduction of at least 75% at visit 2 were classified as responder. This subgroup contains the responder within the Fumaric acid esther group.

    Subject analysis set title
    Non-responder within Fumaric acid esther group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients not achieving a PASI reduction of at least 75% at visit 2 were classified as non-responder. This subgroup contains the non-responder within the Fumaric acid esther group.

    Subject analysis set title
    Responder within TNF-alpha-inhibitors
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients achieving a PASI reduction of at least 75% at visit 2 were classified as responder. This subgroup contains the responder within the TNF-alpha-inhibitors arm.

    Subject analysis set title
    Non-responder within TNF-alpha-inhibitors
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients non achieving a PASI reduction of at least 75% at visit 2 were classified as non- responder. This subgroup contains the non-responder within the TNF-alpha-inhibitors group.

    Primary: Comparison of metabolic factors between responder and non-responder

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    End point title
    		 Comparison of metabolic factors between responder and non-responder
    End point description
    Different parameters are compared between responders and non-responders within the treatment groups
    End point type
    Primary
    End point timeframe
    Baseline and up to visit 2
    End point values
    		 Fumaric acid esther TNF-alpha-inhibitors Responder within Fumaric acid esther Non-responder within Fumaric acid esther group Responder within TNF-alpha-inhibitors Non-responder within TNF-alpha-inhibitors
    Number of subjects analysed
    31
    23
    6
    13
    11
    10
    Units: patients
        responder
    6
    11
    6
    0
    11
    0
        non-responder
    13
    10
    0
    13
    0
    10
    Statistical analysis title
    		 Age in FAE
    Statistical analysis description
    Comparison of age between responder and non-responder within the Fumaric acis esther group
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7356
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 Age in TNF-alpha-inhibitors
    Statistical analysis description
    Comparison of age between responder and non-responder within the TNF-alpha-inhibitor group
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.783
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 Sex in FAE
    Statistical analysis description
    Comparison of sex between responder and non-responder within the Fumaric acis esther group
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.177
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Sex in TNF-alpha-inhibitors
    Statistical analysis description
    Comparison of sex between responder and non-responder within the TNF-alpha-inhibitor group
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Psoriatic arthritis in FAE
    Statistical analysis description
    Comparison of psoriatic arthritis between responder and non-responder within the Fumaric acis esther group
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Psoriatic arthritis in TNF-alpha-inhibitors
    Statistical analysis description
    Comparison of Psoriatic arthritis between responder and non-responder within the TNF-alpha-inhibitor group
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval
    Statistical analysis title
    		 Height in FAE
    Statistical analysis description
    Comparison of height between responder and non-responder within the Fumaric acis esther group.
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4203
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 Height in TNF-alpha-inhibitor
    Statistical analysis description
    Comparison of height between responder and non-responder within the TNF-alpha-inhibitor group.
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0244
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 Weight in FAE
    Statistical analysis description
    Comparison of weight between responder and non-responder within the Fumaric acis esther group
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3035
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 Weight in TNF-alpha-inhibitor
    Statistical analysis description
    Comparison of weight between responder and non-responder within the TNF-alpha-inhibitor group
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8987
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 BMI in FAE
    Statistical analysis description
    Comparison of BMI between responder and non-responder within the Fumaric acis esther group
    Comparison groups
    Responder within Fumaric acid esther v Non-responder within Fumaric acid esther group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1866
    Method
    		 Welch test
    Confidence interval
    Statistical analysis title
    		 BMI in TNF-alpha-inhibitors
    Statistical analysis description
    Comparison of BMI between responder and non-responder within the TNF-alpha-inhibitor group
    Comparison groups
    Responder within TNF-alpha-inhibitors v Non-responder within TNF-alpha-inhibitors
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1463
    Method
    		 Welch test
    Confidence interval

    Primary: Response

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    End point title
    		 Response
    End point description
    Responders defined by PASI score reduction in three categories (>=75%, >=50% & <75%, <50%)
    End point type
    Primary
    End point timeframe
    From study begin to end of treatment
    End point values
    		 Fumaric acid esther TNF-alpha-inhibitors
    Number of subjects analysed
    19 [1]
    21 [2]
    Units: Patients
        Good response
    6
    11
        Satisfactory response
    4
    5
        No response
    9
    5
    Notes
    [1] - Only patients with visit 2 values were analyzed.
    [2] - Only patients with visit 2 values were analyzed.
    Statistical analysis title
    		 Difference in response
    Comparison groups
    Fumaric acid esther v TNF-alpha-inhibitors
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2819
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    In this trial, all AEs and SAEs that occur after the subject has signed the informed consent document until the second visit and biopsy (End of Study) has to be documented.
    Adverse event reporting additional description
    This is a pilot study , therefore, in general, adverse events will not be reported unless •the event is directly related to study participation •the event causes a change in study design •the event is unexpected
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Fumaric acid esther
    Reporting group description
    		 Double- arm open label observational explorative trial; 12 weeks of treatment with fumaric acid esther (Fumarderm® p.o.).

    Reporting group title
    TNF-alpha-inhibitors
    Reporting group description
    		 Double- arm open label observational explorative trial; 12 weeks of Treatment with TNFα-Inhibitors.

    Serious adverse events
    		 Fumaric acid esther TNF-alpha-inhibitors
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 31 (6.45%)
    1 / 23 (4.35%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Gastrointestinal disorders
    intensive gastric pain
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal symptoms
         subjects affected / exposed
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial infection
         subjects affected / exposed
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Fumaric acid esther TNF-alpha-inhibitors
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 31 (25.81%)
    2 / 23 (8.70%)
    Gastrointestinal disorders
    Gastrointestinal symptoms
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    common cold
         subjects affected / exposed
    3 / 31 (9.68%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    Hepatobiliary disorders
    elevation of hepatic paramenter
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Diarrhoea
    Additional description: diarrhea intermittent
         subjects affected / exposed
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Nov 2012
    Change of Investigator
    10 Jan 2013
    Prolongation of recruitment
    14 Jul 2014
    Prolongation of recruitment

    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
    For support, Contact us.
    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
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