{
  "abstract": "Introduction Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.Methods and analysis This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.Ethics and dissemination The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.Trial registration number NCT06037460.",
  "authors": [
    {
      "affiliations": [
        "Service de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France"
      ],
      "name": "Maxime Samson"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Centre d’Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Isabelle Fournel"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Centre d’Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Abderrahmane Bourredjem"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Direction de la Recherche Clinique et de l’Innovation, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Marion Cortier"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Centre d’Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Emilie Galizzi"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Pharmacie, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Amélie Cransac"
    },
    {
      "affiliations": [
        "Service de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France"
      ],
      "name": "Claudie Cladière"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Direction de la Recherche Clinique et de l’Innovation, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Camille Fleck"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Direction de la Recherche Clinique et de l’Innovation, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Marion Brayer"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Direction de la Recherche Clinique et de l’Innovation, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Maud Carpentier"
    },
    {
      "affiliations": [
        "Médecine nucléaire, Centre Georges-Francois Leclerc, Dijon, France",
        "Institut de Chimie Moléculaire de l’Université de Bourgogne, ICMUB UMR CNRS 6302, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Jean-Louis Alberini"
    },
    {
      "affiliations": [
        "CHU Dijon Bourgogne, Centre d’Investigation Clinique, module épidémiologie clinique, INSERM, CIC 1432, Université Bourgogne Europe, Dijon, France"
      ],
      "name": "Hervé Devilliers"
    },
    {
      "affiliations": [
        "Service de Médecine Interne et Immunologie Clinique, CHU Dijon Bourgogne, Université Bourgogne Europe, Centre de Référence Maladies Rares Maladies auto-immunes et autoinflammatoires systémiques rares, Dijon, France"
      ],
      "name": "Bernard Bonnotte"
    }
  ],
  "title": "Immediate versus gradual TocilizuMab discontinuAtion in GIant Cell Arteritis: protocol of the multicentre randomised open-label MAGICA trial",
  "uid": "05f71607-5bec-526b-85de-e387bc174350"
}