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    Clinical Trial Results:
    A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis EYEGUARD TM -B

    Summary
    EudraCT number
    2012-001125-27
    Trial protocol
    GB   DE   GR   PT   IT   ES  
    Global end of trial date
    29 Sep 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    18 Sep 2016
    First version publication date
    18 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL3-78989-002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01965145
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France,
    Public contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com
    Scientific contact
    Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com
    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
    29 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of Behçet’s disease uveitis exacerbations
    Protection of trial subjects
    The study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
    Background therapy
    Standard of care including oral corticosteroids and immunosuppressive therapy (azathioprine, mycophenolate mofetil / mycophenolate sodium, cyclosporine-A and/or methotrexate alone or in any combination)
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Greece: 7
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Armenia: 6
    Country: Number of subjects enrolled
    Brazil: 2
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Israel: 3
    Country: Number of subjects enrolled
    Russian Federation: 2
    Country: Number of subjects enrolled
    Korea, Republic of: 21
    Country: Number of subjects enrolled
    Tunisia: 1
    Country: Number of subjects enrolled
    Turkey: 24
    Worldwide total number of subjects
    84
    EEA total number of subjects
    24
    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)
    83
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients with a history of Behçet’s disease with ocular involvement of the posterior segment, and having experienced at least 2 ocular exacerbations within the 18 months prior to selection, with the most recent having occurred within the last 4 months and having been treated successfully with high dose corticosteroids

    Period 1
    Period 1 title
    Part 1 (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Gevokizumab
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Gevokizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ­ Subcutaneous dose of 60 mg gevokizumab beginning on Day 0 and administered every 4 weeks

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    ­Subcutaneous dose of placebo beginning on Day 0 and administered every 4 weeks

    Number of subjects in period 1
    Gevokizumab Placebo
    Started
    41
    43
    Completed
    0
    0
    Not completed
    41
    43
         Protocol deviation
    -
    2
         non-medical reason
    6
    4
         study discontinuation
    34
    34
         Adverse event, non-fatal
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gevokizumab
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    Gevokizumab Placebo Total
    Number of subjects
    41 43 84
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    41 42 83
        From 65-84 years
    0 1 1
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.3 ± 9.6 35.1 ± 9.5 -
    Gender categorical
    Units: Subjects
        Female
    12 12 24
        Male
    29 31 60

    End points

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    End points reporting groups
    Reporting group title
    Gevokizumab
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Primary: Time to first acute ocular exacerbation over the Core study period

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    End point title
    Time to first acute ocular exacerbation over the Core study period
    End point description
    End point type
    Primary
    End point timeframe
    Duration of the core study period (event-driven), i.e. until the occurence of the 29th ocular exacerbation
    End point values
    Gevokizumab Placebo
    Number of subjects analysed
    40
    43
    Units: number of pts with a 1st exacerbation
    14
    15
    Statistical analysis title
    Cox's proportional hazard model adjusted
    Comparison groups
    Placebo v Gevokizumab
    Number of subjects included in analysis
    83
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.661
    Method
    Cox model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.41
         upper limit
    1.77

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    EAEs reported during the Part 1 (i.e. the core study and the double masked extension period)
    Adverse event reporting additional description
    Emergent adverse events are presented (EAEs) . EAEs on treatment were defined as all adverse events which occurred between the first injection date (included) and the last study drug injection date + 25 days (included), or which worsened or became serious.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Gevokizumab
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Gevokizumab Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 41 (31.71%)
    14 / 43 (32.56%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    5 / 41 (12.20%)
    5 / 43 (11.63%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular ischaemia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 43 (4.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitic glaucoma
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep disorder
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Gevokizumab Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 41 (90.24%)
    40 / 43 (93.02%)
    Vascular disorders
    Behcet's syndrome
         subjects affected / exposed
    23 / 41 (56.10%)
    25 / 43 (58.14%)
         occurrences all number
    56
    67
    Hypertension
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 43 (4.65%)
         occurrences all number
    3
    2
    Investigations
    Blood triglycerides increased
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    4
    Intraocular pressure increased
         subjects affected / exposed
    5 / 41 (12.20%)
    4 / 43 (9.30%)
         occurrences all number
    9
    6
    C-reactive protein increased
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 43 (6.98%)
         occurrences all number
    2
    4
    Mycobacterium tuberculosis complex test positive
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 43 (6.98%)
         occurrences all number
    2
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 43 (4.65%)
         occurrences all number
    3
    3
    Headache
         subjects affected / exposed
    8 / 41 (19.51%)
    6 / 43 (13.95%)
         occurrences all number
    13
    7
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 41 (4.88%)
    6 / 43 (13.95%)
         occurrences all number
    2
    8
    Eye pain
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 43 (6.98%)
         occurrences all number
    4
    3
    Macular oedema
         subjects affected / exposed
    4 / 41 (9.76%)
    14 / 43 (32.56%)
         occurrences all number
    11
    33
    Vision blurred
         subjects affected / exposed
    5 / 41 (12.20%)
    0 / 43 (0.00%)
         occurrences all number
    11
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Fatigue
         subjects affected / exposed
    0 / 41 (0.00%)
    6 / 43 (13.95%)
         occurrences all number
    0
    16
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Abdominal pain
         subjects affected / exposed
    4 / 41 (9.76%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    Constipation
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Diarrhoea
         subjects affected / exposed
    4 / 41 (9.76%)
    4 / 43 (9.30%)
         occurrences all number
    5
    5
    Nausea
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Skin and subcutaneous tissue disorders
    Swelling face
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 41 (12.20%)
    2 / 43 (4.65%)
         occurrences all number
    5
    2
    Myalgia
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 43 (6.98%)
         occurrences all number
    5
    3
    Back pain
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 43 (9.30%)
         occurrences all number
    0
    4
    Pain in extremity
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    6 / 41 (14.63%)
    6 / 43 (13.95%)
         occurrences all number
    7
    7
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 41 (9.76%)
    3 / 43 (6.98%)
         occurrences all number
    6
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Aug 2012
    − Precision in contraception methods; − Introduction of 6 months wash out period for subtenonian triamcinolone acetonide; − Introduction of macular oedema as a rescue criterion; − Introduction of OCT at each visit with ophthalmologic exam − Additional tests for HIV, HCV, hepatitis B and IGRA
    07 Nov 2013
    ­- Increase the statistical power from 80% to 90% while maintaining the same hazard ratio and type one error rate planned in the protocol for the determination of the number of events. ­- Eliminate the upper weight limit of 120 kg in the selection criteria. ­- Extend the delay between selection (ASSE) and inclusion (D0) from 7 to 10 days.
    28 Jan 2015
    ­- Update of the study completion date. ­- Postponment of immune competence assessment - Cessation of laboratory sampling for cytokines, vascular markers, genomics / other omics after the end of the Core study

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Jul 2015
    At the end of the Core study period, the study discontinuation was decided owing to Sponsor’s decision, (primary endpoint not achieved). Consequently the 1-year double masked extension period had been prematurely stopped and the open long-term safety follow-up period was not carried on.
    -

    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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