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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

Trial Profile

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Interstitial lung diseases; Systemic scleroderma
  • Focus Registrational; Therapeutic Use
  • Acronyms focuSSced
  • Sponsors Chugai Pharmaceutical; Roche
  • Most Recent Events

    • 19 May 2021 Results of a post hoc analysis assessing the safety and efficacy of a subset of patients who had Systemic Sclerosis Interstitial Lung Disease at baseline, as evidenced by high-resolution computed tomography presented at the 117th International Conference of the American Thoracic Society
    • 19 May 2021 Results (n=136) of post-hoc analyses assessing the SSc-ILD at baseline, high-resolution computed tomography, Lung function assessed by change from baseline to week 48 in absolute forced vital capacity and percent-predicted forced vital capacity in patients with SSc-ILD, presented at the 117th International Conference of the American Thoracic Society.
    • 04 Mar 2021 According to a Genentech media release, the U.S. Food and Drug Administration (FDA) approved Actemra (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The FDA approval is based on data from the focuSSced trial.Supportive information was also used from the faSScinate trial.
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