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Tocilizumab Real-Life Human Factors Validation Study

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Trial Profile

Tocilizumab Real-Life Human Factors Validation Study

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Roche

    • Most Recent Events

    • 26 Nov 2018 According to a Genentech media release, the U.S. FDA has approved ACTPen 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis (PJIA and SJIA).This approval of the ACTPen is based on clinical data from the phase I bioequivalence study (NCT02678988) and this phase IV human factors study (NCT02682823), presented at the ASCPT-2018.
    • 24 Mar 2018 Results presented at the 119th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 01 Sep 2016 Status changed from recruiting to completed.
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