None listed
Conditions
Interventions
Prefilled glass syringes of sarilumab 150 mg or 200 mg or placebo. Route(s) of administration: Subcutaneous (SC) in abdomen, thigh, or upper arm. Dose regimen: Sarilumab 150 or 200 mg, or placebo is
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of rheumatoid arthritis ≥6 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria • ACR Class I-III functional status, based on 1991 revised criteria • Patients who, per Investigator assessment, have had an inadequate response to at least one TNF antagonist, after being treated for at least 3 consecutive months, any time before screening or patients intolerant to at least 1 TNF antagonist, resulting in discontinuation - TNF-antagonists may include etanercept, infliximab, adalimumab, golimumab and/or certolizumab pegol • Active disease defined as: - at least 6 of 66 swollen joints and 8 of 68 tender at screening and baseline visits, and - hs-CRP ≥8 mg/L at screening • Continuous treatment with one or a combination of non-biologic DMARDs (except for simultaneous combination use of leflunomide and methotrexate) for at least 12 consecutive weeks prior to randomization and on a stable dose(s) for at least 6 consecutive weeks prior to screening. Patients who have signed a written informed consent prior to performance of any study-related procedures.
Exclusion criteria
Exclusion criteria: • Age <18 years • Treatment with TNF antagonists as follows: - Etanercept: Within 28 days prior to randomization - Infliximab, adalimumab, golimumab and certolizumab pegol: Within 42 days prior to randomization • Treatment with RA-directed biologic agents with non-TNF-α antagonist mechanisms as follows: - Anakinra: Within 28 days prior to randomization - Abatacept: Within 42 days prior to randomization - Rituximab or other cell depleting agent: Within 6 months prior to randomization or until total lymphocyte count and CD 19+ lymphocyte count are normalized, whichever is longer • 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 • Use of oral glucocorticoid greater than prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks prior to randomization • Use of parenteral glucocorticoids or intra-articular glucocorticoids within 4 weeks prior to randomization
Countries
Argentina, Australia, Austria, Belgium, Canada, Chile, Colombia, Czech Republic, Ecuador, Estonia, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Korea North, Lithuania, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactKatia Lourdes Meza
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed