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    Clinical Trial Results:
    The induction of apoptosis by anti-psoriatic treatments

    Summary
    EudraCT number
    2005-000707-34
    Trial protocol
    GB  
    Global end of trial date
    30 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    06 May 2020
    First version publication date
    06 May 2020
    Other versions
    Summary report(s)
    2005-000707-34 Final report

    Trial information

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    Trial identification
    Sponsor protocol code
    2316
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    RVI, Queen Victoria Road, Newcastle upon Tyne, United Kingdom, NE1 4LP
    Public contact
    Professor Nick Reynolds, Newcastle University, +44 191 208 5840, nick.reynolds@ncl.ac.uk
    Scientific contact
    Professor Nick Reynolds, Newcastle University, +44 191 208 5840, nick.reynolds@ncl.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
    26 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To define the molecular mechanism of action of various routine treatments used in the management of psoriasis. We aim to study apoptosis/autophagy in psoriatic skin biopsies during the clinical resolution of psoriatic plaques in response to a variety of treatments and correlate this with clinical improvement
    Protection of trial subjects
    A Trial Steering Committee (TSC) was in place to supervise the trial to ensure it was conducted to the highest standards in accordance with the protocol, GCP, ethical principles and with regards to patient safety. Patient safety was also assessed via appropriate safety reporting.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Nov 2002
    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: 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)
    36
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited in to the study from one site (The Newcastle upon Tyne Hospitals NHS Foundation Trust) who were about to commence anti-psoriatic treatment and who met the inclusion/exclusion criteria. Written informed consent was required from all patients. First patient was recruited 04/06/2003; last patient was recruited 17/07/2013.

    Pre-assignment
    Screening details
    Patients were recruited who were about to commence anti-psoriatic treatment and who meet the inclusion/exclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adalimumab
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Etanercept
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPCs

    Arm title
    Ustekinumab
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPCs

    Arm title
    Adalimumab combined with Methotrexate
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPCs

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPCs

    Arm title
    Acitretin
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Acitretin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Ciclosporin
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Ciclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Fumaric Acid Esters
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Fumaric Acid Esters
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Ointment
    Routes of administration
    Oral use, Topical use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Methotrexate
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Oral PUVA
    Arm description
    Phototherapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Oral PUVA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Dithranol
    Arm description
    Topical treatment
    Arm type
    Active comparator

    Investigational medicinal product name
    Dithranol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Number of subjects in period 1
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate Oral PUVA Dithranol
    Started
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1
    Completed
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1
    Period 2
    Period 2 title
    Treatment
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adalimumab
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Etanercept
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Ustekinumab
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Adalimumab combined with Methotrexate
    Arm description
    Biologic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Adalimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis and Use of Biological Interventions in Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Acitretin
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Acitretin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Ciclosporin
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Ciclosporin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Fumaric Acid Esters
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Fumaric Acid Esters
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Ocular use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Methotrexate
    Arm description
    Conventional (non-biologic) systemic therapy
    Arm type
    Active comparator

    Investigational medicinal product name
    Methotrexate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    oral PUVA
    Arm description
    Phototherapy
    Arm type
    Active comparator

    Investigational medicinal product name
    oral PUVA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Arm title
    Dithranol
    Arm description
    Topical treatment
    Arm type
    Active comparator

    Investigational medicinal product name
    Dithranol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    According to National guidelines (British Association of Dermatologists Psoriasis) for the therapeutic indications, contraindications and monitoring of therapies, combined with specific issues specified in SmPC

    Number of subjects in period 2
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate oral PUVA Dithranol
    Started
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1
    Completed
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Etanercept
    Reporting group description
    Biologic therapy

    Reporting group title
    Ustekinumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Adalimumab combined with Methotrexate
    Reporting group description
    Biologic therapy

    Reporting group title
    Acitretin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Ciclosporin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Fumaric Acid Esters
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Methotrexate
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Oral PUVA
    Reporting group description
    Phototherapy

    Reporting group title
    Dithranol
    Reporting group description
    Topical treatment

    Reporting group values
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate Oral PUVA Dithranol Total
    Number of subjects
    2 3 2 1 12 2 1 14 2 1 40
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    2 3 1 1 9 2 1 14 2 1 36
        From 65-84 years
    0 0 1 0 3 0 0 0 0 0 4
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    1 1 1 0 1 1 0 6 1 1 13
        Male
    1 2 1 1 11 1 1 8 1 0 27

    End points

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    End points reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Etanercept
    Reporting group description
    Biologic therapy

    Reporting group title
    Ustekinumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Adalimumab combined with Methotrexate
    Reporting group description
    Biologic therapy

    Reporting group title
    Acitretin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Ciclosporin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Fumaric Acid Esters
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Methotrexate
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Oral PUVA
    Reporting group description
    Phototherapy

    Reporting group title
    Dithranol
    Reporting group description
    Topical treatment
    Reporting group title
    Adalimumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Etanercept
    Reporting group description
    Biologic therapy

    Reporting group title
    Ustekinumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Adalimumab combined with Methotrexate
    Reporting group description
    Biologic therapy

    Reporting group title
    Acitretin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Ciclosporin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Fumaric Acid Esters
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Methotrexate
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    oral PUVA
    Reporting group description
    Phototherapy

    Reporting group title
    Dithranol
    Reporting group description
    Topical treatment

    Primary: Psoriasis Area Severity Index (PASI)

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    End point title
    Psoriasis Area Severity Index (PASI)
    End point description
    PASI is a validated scoring system to assess psoriasis severity. PASI 75 represents the percentage of patients who have achieved a 75% or more reduction in their PASI score from baseline. PASI75 calculation – We compared the latest PASI available with the earliest PASI
    End point type
    Primary
    End point timeframe
    Dates related to the PASI scores – We calculated the date of the PASI compared to: - The drug start date on or around the baseline - The baseline PASI (or visit date if no baseline PASI)
    End point values
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate oral PUVA Dithranol
    Number of subjects analysed
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1
    Units: Subject’s percentage achieving PASI75
        number (not applicable)
    2
    3
    2
    1
    12
    2
    1
    14
    2
    1
    Statistical analysis title
    Descriptive statistics
    Comparison groups
    Adalimumab v Adalimumab combined with Methotrexate v Ustekinumab v Etanercept v Acitretin v Ciclosporin v Fumaric Acid Esters v Methotrexate v oral PUVA v Dithranol
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0 [2]
    Method
    Descriptive statistics
    Parameter type
    not applicable
    Confidence interval
    Notes
    [1] - Percentage of PASI75 responders, mean percentage change in PASI
    [2] - Not applicable

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    SAEs were reported immediately to the Principal Investigator and were reported from when patients were consented through to last patient last visit.
    Adverse event reporting additional description
    One SUSAR report in the UK
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    Protocol
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    Adalimumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Etanercept
    Reporting group description
    Biologic therapy

    Reporting group title
    Ustekinumab
    Reporting group description
    Biologic therapy

    Reporting group title
    Adalimumab combined with Methotrexate
    Reporting group description
    Biologic therapy

    Reporting group title
    Acitretin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Ciclosporin
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Fumaric Acid Esters
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Methotrexate
    Reporting group description
    Conventional (non-biologic) systemic therapy

    Reporting group title
    Oral PUVA
    Reporting group description
    Phototherapy

    Reporting group title
    Dithranol
    Reporting group description
    Topical treatment

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The study team maintained a central record of AEs, SAEs in the combined Trial Master File / Investigator Site File (single center study). No other safety events were reported apart from one SUSAR. No Adverse Events were recorded in the CRFs.
    Serious adverse events
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate Oral PUVA Dithranol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myositis
    Additional description: Myositis secondary to long term drug treatment of Simvastatin & Acitretin. Patient admitted to hospital to monitor muscle weakness. Both Acitretin & Simvastatin were stopped.
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    1 / 12 (8.33%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adalimumab Etanercept Ustekinumab Adalimumab combined with Methotrexate Acitretin Ciclosporin Fumaric Acid Esters Methotrexate Oral PUVA Dithranol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 12 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 14 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Oct 2011
    Protocol amendment: • Change in protocol title • Inclusion of healthy tissue samples (new wording) • Addition of 2 new drugs (Ustekinumab, Adalimumab)

    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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