A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Sep 2017

At a glance

  • Drugs Tocilizumab (Primary) ; Methotrexate; Prednisone
  • Indications Giant cell arteritis
  • Focus Registrational; Therapeutic Use
  • Acronyms GiACTA
  • Sponsors Roche
  • Most Recent Events

    • 22 Sep 2017 According to a Roche media release, Actemra/RoActemra was approved for the treatment of giant cell arteritis by New Zealand's Medsafe in May 2017.
    • 22 Sep 2017 According to a Roche media release, the European Commission (EC) has approved Actemra/RoActemra (tocilizumab) for the treatment of giant cell arteritis. The approval is based on data from this trial.
    • 25 Aug 2017 According to a Chugai Pharmaceuticals media release, based on the results from this and MRA632JP study, the company obtained an approval Actemra 162mg Syringe for subcutaneous (SC) Injection and Actemra 162mg Auto-Injector for SC Injection by the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional indications of Takayasu arteritis (TAK) and giant cell arteritis (GCA) that have not responded sufficiently to existing therapies.
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