A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

Trial Profile

A Randomized, Double-blind, Parallel-group Study Assessing the Efficacy and Safety of Sarilumab Monotherapy Versus Adalimumab Monotherapy in Patients With Rheumatoid Arthritis

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2017

At a glance

  • Drugs Sarilumab (Primary) ; Adalimumab
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms MONARCH; SARIL-RA-MONARCH
  • Sponsors Regeneron Pharmaceuticals; Sanofi
  • Most Recent Events

    • 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).
    • 17 Jun 2017 Results comparing patient-reported outcomes with sarilumab vs adalimumab, presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results of patients reported outcomes data from two studies ( TARGET and MONARCH), presented at the 18th Annual Congress of the European League Against Rheumatism
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