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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)
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)

NCT02293902

CompletedPhase 3

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis

Interventions: Sarilumab SAR153191 (REGN88), Placebo (for sarilumab), Methotrexate, Folic acid

Countries: Japan

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. Secondary Objective: -To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.

Eligibility overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (96)
  • Asahi-Shi, Japan
  • Asahikawa-Shi, Japan
  • Asahikawa-Shi, Japan
  • Beppu-Shi, Japan
  • Chiba, Japan
  • Chūōku, Japan
  • Fuchu-Shi, Japan
  • Fukui-shi, Japan
  • Fukuoka, Japan
  • Fukuoka, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Funabashi-Shi, Japan
  • Hachioji-Shi, Japan
  • Hannan-Shi, Japan
  • Hiroshima, Japan
  • Hiroshima, Japan
  • Hitachi-Naka, Japan
  • Hitachi-Naka, Japan
  • Ichinomiya-Shi, Japan
  • Iizuka-Shi, Japan
  • Kagoshima, Japan
  • Kamakura-Shi, Japan
  • Kamogawa-Shi, Japan
  • Kato-Shi, Japan
  • Kawachi-Nagano-Shi, Japan
  • Kawagoe-Shi, Japan
  • Kawasaki-Shi, Japan
  • Kirishima-Shi, Japan
  • Kitakyushu-Shi, Japan
  • + 66 more on CT.gov