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A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

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Trial Profile

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Systemic scleroderma
  • Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
  • Acronyms faSScinate
  • Sponsors Roche

    • Most Recent Events

    • 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.
    • 01 Jun 2018 Results assessing the prognostic skin Biomarkers for the progression of skin fibrosis (n=38) published in the Arthritis and Rheumatology
    • 31 May 2018 Results (n=12) aiming to elucidate the specific effect of IL-6 pathway blockade on the biology of SSc fibroblasts in vivo by using samples from a unique clinical experiment-the faSScinate study published in the Annals of the Rheumatic Diseases
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