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A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

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Trial Profile

A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Nov 2022

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At a glance

  • Drugs Sarilumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms KAKEHASI; SARIL-RA-KAKEHASI
  • Sponsors Sanofi

    • Most Recent Events

    • 28 Oct 2022 Results of post-hoc analysis assessing potential relationships between haemoglobin and disease activity in Japanese patients with rheumatoid arthritis, published in the Clinical and Experimental Rheumatology.
    • 22 May 2017 According to a Sanofi media release, based on the data from approximately 2,900 adults the US FDA has approved Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more DMARDs, such as methotrexate (MTX).
    • 28 Apr 2017 According to a Regeneron Pharmaceuticals media release, the US FDA has accepted the resubmission of the Biologics License Application for sarilumab (Kevzara) as a Class I response with a two month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017.
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