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    Clinical Trial Results:
    An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Subjects with Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently having Flare or Persisting Disease Activity.

    Summary
    EudraCT number
    2016-002716-41
    Trial protocol
    FR  
    Global end of trial date
    23 Aug 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Sep 2020
    First version publication date
    05 Sep 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ML39425
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03202368
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, Roche Trial Information Hotline, +41 61 6878333, global.trial_information@roche.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
    01 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multicenter, interventional, open-label, long-term extension study of Study WA28119 (NCT01791153) to evaluate the long-term safety of SC tocilizumab in subjects with GCA who subsequently have flare or persisting disease activity.
    Protection of trial subjects
    All study subjects were required to read and sign and Informed Consent Form. The study was conducted in accordance with the principles of the “Declaration of Helsinki” and Good Clinical Practice.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Oct 2017
    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
    France: 3
    Worldwide total number of subjects
    3
    EEA total number of subjects
    3
    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)
    0
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119, will receive SC tocilizumab in this study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Arm description
    Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119.
    Arm type
    Experimental

    Investigational medicinal product name
    Tocilizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first.

    Number of subjects in period 1
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Started
    3
    Completed
    2
    Not completed
    1
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119.

    Reporting group values
    Overall Study Total
    Number of subjects
    3 3
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    3 3
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    74.7 ± 3.8 -
    Gender Categorical
    Units: Subjects
        Female
    3 3
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Reporting group description
    Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119.

    Primary: Percentage of subjects with Adverse Events

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    End point title
    Percentage of subjects with Adverse Events [1]
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline
    End point type
    Primary
    End point timeframe
    Baseline up to 160 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis provided.
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    3
    Units: Percentage
    number (not applicable)
        Adverse Events
    100
        Serious Adverse Events
    33.3
    No statistical analyses for this end point

    Secondary: GCA Disease Activity, as Assessed by the Investigator Based on Visual Analogue Scale Score

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    End point title
    GCA Disease Activity, as Assessed by the Investigator Based on Visual Analogue Scale Score
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 156
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [2]
    Units: Points on Scale
    Notes
    [2] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score

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    End point title
    Patient Global Assessment of Disease Activity Disease Activity, as Assessed Based on Visual Analogue Scale Score
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 156
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [3]
    Units: Points on Scale
    Notes
    [3] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Erythrocyte Sedimentation Rate Values

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    End point title
    Change from Baseline in Erythrocyte Sedimentation Rate Values
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 156
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [4]
    Units: mm/hr
    Notes
    [4] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-Reactive Protein Values

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    End point title
    Change from Baseline in C-Reactive Protein Values
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0), Weeks 48, 96, 156
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [5]
    Units: mg/L
    Notes
    [5] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab

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    End point title
    Number of Subjects Who Receive Concomitant Medications With SC Tocilizumab
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline up to 156 weeks
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [6]
    Units: Number of subjects
    Notes
    [6] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Number of SC Tocilizumab Injections Administered

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    End point title
    Number of SC Tocilizumab Injections Administered
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline up to 156 weeks
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [7]
    Units: Number
    Notes
    [7] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Total SC Tocilizumab Dose Administered

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    End point title
    Total SC Tocilizumab Dose Administered
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline up to 156 weeks
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [8]
    Units: Number
    Notes
    [8] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Duration of SC Tocilizumab Treatment

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    End point title
    Duration of SC Tocilizumab Treatment
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline up to 156 weeks
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [9]
    Units: Weeks
    Notes
    [9] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Duration of SC Tocilizumab Interruption

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    End point title
    Duration of SC Tocilizumab Interruption
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline up to 156 weeks
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [10]
    Units: Weeks
    Notes
    [10] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Secondary: Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study

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    End point title
    Duration Between Last Tocilizumab Administration in Study WA28119 and First Tocilizumab Administration in Current Study
    End point description
    Due to the limited number of analyzed subjects (n=3), only descriptive analysis at each study visit was performed, with no change from baseline.
    End point type
    Secondary
    End point timeframe
    From last tocilizumab administration in Study WA28119 to first tocilizumab administration in current study (approximately up to 3 years; assessed retrospectively at Baseline)
    End point values
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Number of subjects analysed
    0 [11]
    Units: Weeks
    Notes
    [11] - Only descriptive analysis at each study visit was performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 160 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Reporting group description
    Subjects who were treated with tocilizumab in Study WA28119 and experienced a new GCA flare within 3 years after completion of Study WA28119 or had persistent active GCA at the time of completion of Study WA28119.

    Serious adverse events
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 3 (33.33%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Trachycardia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Tocilizumab: GCA Flare or Persistent Disease Activity
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Urticarial vasculitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Rheumatic disorder
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Periodontitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Erysipelas
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Tracheitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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