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Status:

COMPLETED

A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

Lead Sponsor:

Sanofi

Collaborating Sponsors:

Regeneron Pharmaceuticals

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

20-75 years

Phase:

PHASE3

Brief Summary

Primary Objective: -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX. S...

Detailed Description

The total duration of study was expected up to 62 weeks (screening period of 4 weeks, treatment period of 52 weeks, and a 6-week post treatment observation).

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \>=3 months disease duration.
  • Moderately to severely active RA defined as:
  • At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
  • High sensitivity C-Reactive Protein (hs-CRP) \>=6mg/L at screening visit.
  • Exclusion criteria:
  • Participants \<20 or \>75 years of age.
  • Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
  • Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    November 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2016

    Estimated Enrollment :

    243 Patients enrolled

    Trial Details

    Trial ID

    NCT02293902

    Start Date

    November 1 2014

    End Date

    October 1 2016

    Last Update

    January 30 2018

    Active Locations (96)

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    Page 1 of 24 (96 locations)

    1

    Investigational Site Number 392010

    Asahi-Shi, Japan

    2

    Investigational Site Number 392001

    Asahikawa-Shi, Japan

    3

    Investigational Site Number 392035

    Asahikawa-Shi, Japan

    4

    Investigational Site Number 392070

    Beppu-Shi, Japan