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    Clinical Trial Results:
    Efficacité et tolérance d'un traitement de première intention par tocilizumab dans la maladie de Takayasu: étude française multicentrique prospective

    Summary
    EudraCT number
    		 2013-005039-26
    Trial protocol
    		 FR  
    Global end of trial date
    01 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2022
    First version publication date
    29 Jun 2022
    Other versions
    Summary report(s)
    		 Résumé du rapport final

    Trial information

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    Trial identification
    Sponsor protocol code
    P130404
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02101333
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
    Sponsor organisation address
    4 Avenue Victoria, PARIS, France, 75004
    Public contact
    Yannick VACHER, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, yannick.vacher@aphp.fr
    Scientific contact
    Pr Olivier FAIN, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, yannick.vacher@aphp.fr
    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
    10 Feb 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Etudier l'influence d'un traitement par tocilizumab pendant 6 mois sur le nombre de patients bons répondeurs ayant pu arrêter les corticoïdes.
    Protection of trial subjects
    Le déroulement de la recherche dans les centres investigateurs et la prise en charge des sujets sera fait conformément à la déclaration d’Helsinki et les Bonnes Pratiques en vigueur. Cette recherche a obtenu l'avis favorable du CPP Ile de France X le 16/01/2014
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2014
    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: 17
    Worldwide total number of subjects
    17
    EEA total number of subjects
    17
    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)
    17
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 L'étude a été conçue comme une étude multicentrique avec 27 sites investigateurs en France. 15 patients atteints de la Maladie de Takayasu devait être inclus dans l'étude. Une MS a augmenté le nombre de sujets à inclure afin d'avoir 15 patients analysables

    Pre-assignment
    Screening details
    		 17 patients ont été inclus dans la recherche dans 12 centres en France

    Period 1
    Period 1 title
    Patients inclus
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients ayant signé le consentement
    Arm description
    		 Signature du consentement
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Patients ayant signé le consentement
    Started
    17
    Completed
    14
    Not completed
    3
         Physician decision
    3
    Period 2
    Period 2 title
    Patients ayant initié le traitement
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Bras unique
    Arm description
    		 Administration de Tocilizumab pendant au minimum un mois
    Arm type
    		 Experimental

    Investigational medicinal product name
    RoActemra
    Investigational medicinal product code
    86045397
    Other name
    TOCILIZUMAB
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tous les patients bénéficieront d’un traitement par tocilizumab, qui sera administré selon les recommandations en vigueur, à 8 mg/kg en une injection intraveineuse sur 1 heure associé à la surveillance habituelle prévue. Le tocilizumab sera administré selon les mêmes modalités à M0, puis de façon mensuelle pendant 6 mois.

    Number of subjects in period 2
    		Bras unique
    Started
    14
    Completed
    13
    Not completed
    1
         Protocol deviation
    1
    Period 3
    Period 3 title
    Patients ayant été traité 6 mois
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Patients analysés
    Arm description
    		 Administration du Tocilizumab pendant les 6 premiers mois de l'étude
    Arm type
    		 Experimental

    Investigational medicinal product name
    RoActemra
    Investigational medicinal product code
    86045397
    Other name
    TOCILIZUMAB
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tous les patients bénéficieront d’un traitement par tocilizumab, qui sera administré selon les recommandations en vigueur, à 8 mg/kg en une injection intraveineuse sur 1 heure associé à la surveillance habituelle prévue. Le tocilizumab sera administré selon les mêmes modalités à M0, puis de façon mensuelle pendant 6 mois.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: 3 patients inclus n'ont reçu aucune perfusion de Tocilizumab et 1 patient a été inclus à tord mais a reçu une perfusion de Tocilizumab la Période baseline correspond aux patients ayant reçu au moins une perfusion de Tocilizumab et n'ayant pas été inclus à tord
    Number of subjects in period 3 [2]
    		Patients analysés
    Started
    13
    Completed
    13
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 3 patients inclus n'ont reçu aucune perfusion de Tocilizumab et 1 patient a été inclus à tord mais a reçu une perfusion de Tocilizumab la Période baseline correspond aux patients ayant reçu au moins une perfusion de Tocilizumab et n'ayant pas été inclus à tord

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients ayant été traité 6 mois
    Reporting group description
    		 -

    Reporting group values
    		 Patients ayant été traité 6 mois Total
    Number of subjects
    		 13 13
    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)
    		 13 13
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 32 (19 to 45) -
    Gender categorical
    Units: Subjects
        Female
    		 12 12
        Male
    		 1 1
    Origine ethnique
    Units: Subjects
        Caucasienne
    		 7 7
        Afrique du Nord
    		 4 4
        Autre
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Patients ayant signé le consentement
    Reporting group description
    		 Signature du consentement
    Reporting group title
    Bras unique
    Reporting group description
    		 Administration de Tocilizumab pendant au minimum un mois
    Reporting group title
    Patients analysés
    Reporting group description
    		 Administration du Tocilizumab pendant les 6 premiers mois de l'étude

    Primary: Nombre de bons répondeurs en rémission complète ayant arrêté les corticoïdes après 6 mois de traitement par tocilizumab

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    End point title
    		 Nombre de bons répondeurs en rémission complète ayant arrêté les corticoïdes après 6 mois de traitement par tocilizumab [1]
    End point description
    La rémission complète étant définie par l’absence d’activité clinique, biologique et radiologique à 6 mois
    End point type
    Primary
    End point timeframe
    6 mois après le début du traitemen
    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: L'étude TOCITAKA n'est pas une étude comparative
    End point values
    		 Patients analysés
    Number of subjects analysed
    13
    Units: Nombre de patients
        Succès
    6
        Echec
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    18 mois et 21 jours
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Bras unique
    Reporting group description
    		 -

    Serious adverse events
    		 Bras unique
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 13 (30.77%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vasospasm cerebral
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    acute pancreatitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Polyarthritis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    polyarthralgia
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    perianal abcess
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    infectious colitis
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bras unique
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 13 (69.23%)
    Blood and lymphatic system disorders
    asymptomatic neutropenia
    alternative dictionary used: NA NA
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Otitis
    alternative dictionary used: NA NA
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    3
    Gastrointestinal disorders
    viral gastroenteritis
    alternative dictionary used: NA NA
         subjects affected / exposed
    2 / 13 (15.38%)
         occurrences all number
    0
    acute pancreatitis
    alternative dictionary used: NA NA
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    rhinopharyngitis
    alternative dictionary used: NA NA
         subjects affected / exposed
    3 / 13 (23.08%)
         occurrences all number
    3
    Infections and infestations
    urinary tract infection
    alternative dictionary used: NA NA
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1
    Thoracic zona
    alternative dictionary used: NA NA
         subjects affected / exposed
    1 / 13 (7.69%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2014
    - ajout d'un nouveau centre - mise à jour du formulaire de notification d'EIG
    15 Dec 2014
    Ajout du centre 024 (service de Médecine interne, Diabète et Maladies métaboliques, CHRU de Strasbourg)
    12 Feb 2015
    Centre 023: déménagement du Pr Olivier Fain (investigateur coordonnateur de l'étude) à l'hôpital Saint-Antoine qui devient investigateur principal au niveau du centre
    29 Jun 2015
    - prolongation de la période d'inclusion. La durée totale de la recherche passe ainsi de 30 mois à 54 mois - ajout du centre 025: service de médecine interne et maladies infectieuses, CHU de Bordeaux - ajout de la possibilité de faire un angio-scanner à la place de l'angio-IRM
    28 Sep 2015
    Ajout d'un nouveau centre : Service de Médecine Interne, CHU de Tours o Investigateur principal : Dr Bertrand LIOGER
    03 May 2017
    Prolongation de la période d'inclusion et de l'étude de 6 mois Augmentation du nombre de patients à inclure à 20 afin d'avoir 15 patients évaluables (qui ont été traités)
    25 Sep 2017
    Modification du lieu de conditionnement secondaire du Tocilizumab. o La société Movianto (Gonesse) remplace le Site Logistique Roche (Rosny sous Bois) Modification du lieu de certification du Tocilizumab o Certification à Roche Boulogne-Billancourt (à la place de Roche - Rosny-sous-Bois)
    01 Feb 2018
    - Suppression du Comité de Surveillance Indépendant - Modification de l'investigateur principal du centre 003 (Henri Mondor) o Le Dr Nicolas LIMAL remplace le Pr GODEAU - Modification de l'investigateur principal du centre 026 (Tours) o Le Dr Nicole FERREIRA remplace le Dr LIOGER
    22 Feb 2018
    Modification de l'investigateur principal dans le centre 004 (Médecine Interne 1 - Hôpital Pitié Salpetrière). Le Pr Saadoun remplace le Pr Cacoub
    17 May 2018
    - Ajout d'un nouveau centre : o Service de Médecine vasculaire, CHU de Montpellier o Investigateur principal : Pr Isabelle QUERE

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32943098
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