Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
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

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top