A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Trial Profile

A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2018

At a glance

  • Drugs Sarilumab (Primary) ; Tocilizumab
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; Registrational
  • Acronyms ASCERTAIN; SARIL-RA-ASCERTAIN
  • Sponsors Sanofi
  • Most Recent Events

    • 16 Jun 2018 Long-term five year results from six clinical trials including this trial presented at the 19th Annual Congress of the European League Against Rheumatism.
    • 16 Jun 2018 Results of post hoc analysis examining outcomes for patients who switched from tocilizumab in ASCERTAIN to open-label sarilumab in EXTEND presented at the 19th Annual Congress of the European League Against Rheumatism
    • 27 Jun 2017 According to a Sanofi Genzyme media release, based on the data from seven Phase 3 trials in the global SARIL-RA clinical development program, the European Commission (EC) has granted marketing authorisation for Kevzara (sarilumab) in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
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