A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-alpha Antagonists

Trial Profile

A Randomized, Double-blind, Parallel, Placebo-controlled Study Assessing The Efficacy and Safety of Sarilumab Added To DMARD Therapy In Patients With Rheumatoid Arthritis Who Are Inadequate Responders To Or Intolerant Of TNF-alpha Antagonists

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Aug 2017

At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms RA-TARGET; SARIL-RA-TARGET; TARGET
  • 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 of patients reported outcomes data from two studies ( TARGET and MONARCH), presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results of efficacy endpoint assessed in 3 studies (NCT01061736, NCT01709578 and NCT02332590) presented at the 18th Annual Congress of the European League Against Rheumatism
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