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A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

NCT02373202

CompletedPhase 3

Sponsor: Sanofi

Conditions: Rheumatoid Arthritis

Interventions: Sarilumab, Sulfasalazine, Leflunomide, Bucillamine, Tacrolimus

Countries: Japan

Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

Diagnosis of rheumatoid arthritis (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 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.
* High sensitivity C-Reactive Protein (hs-CRP) \>=4 mg/L or Erythrocyte Sedimentation Rate (ESR) \>=28 mm/hr at screening visit.

For the combination stratum:

Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.

For the monotherapy stratum:

Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.

Exclusion criteria:

Participants \<20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents 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 (40)
  • Asahi-Shi, Japan
  • Asahikawa-Shi, Japan
  • Beppu-Shi, Japan
  • Chiba, Japan
  • Chūōku, Japan
  • Fukui-shi, Japan
  • Fukuoka, Japan
  • Ichinomiya-Shi, Japan
  • Iizuka-Shi, Japan
  • Kagoshima, Japan
  • Kamakura-Shi, Japan
  • Kato-Shi, Japan
  • Kawachi-Nagano-Shi, Japan
  • Kawasaki-Shi, Japan
  • Kitakyushu-Shi, Japan
  • Kochi, Japan
  • Kushiro, Japan
  • Matsuyama, Japan
  • Miyagi-Gun, Japan
  • Nagoya, Japan
  • Nagoya, Japan
  • Narashino-Shi, Japan
  • Okayama, Japan
  • Osaki-Shi, Japan
  • Ōita, Japan
  • Sagamihara-Shi, Japan
  • Sapporo, Japan
  • Sapporo, Japan
  • Sapporo, Japan
  • Sasebo-Shi, Japan
  • + 10 more on CT.gov