None listed
Conditions
Interventions
Single-use prefilled glass syringes of sarilumab 200 mg or placebo. Single-use prefilled glass syringes of adalimumab 40 mg or placebo. Subcutaneous (SC) route, in abdomen or thigh. Sarilumab 200 mg o
Sponsors
Sanofi Aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: At both Screening and Baseline: • Diagnosis of rheumatoid arthritis ≥3 months duration, according to the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010 Rheumatoid Arthritis Classification Criteria (1) • ACR Class I-III functional status, based on 1991 revised criteria (2) • Active RA defined as: - At randomization: at least 6 of 66 swollen joints and 8 of 68 tender joints - Between screening and randomization: High sensitivity C-reactive protein (hs-CRP) ≥8 mg/L or ESR ≥28 mm/H. - At randomization: DAS28ESR > 5.1 using an ESR assessed between screening and randomization. • Patients who per investigator judgment were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continuous treatment with MTX, or inadequate responders treated with an adequate MTX dose (10 to 25 mg/wk, or 6 to 25 mg/wk for patients within Asia-Pacific region) for at least 12 weeks. • Patients must have signed a written informed consent prior to performance of any study-related procedures
Exclusion criteria
Exclusion criteria: • Age <18 years or the legal age of consent in the country of the study site, whichever is higher. • Treatment with any prior biologic agent, including anti-interleukin 6 (IL-6), IL- 6 receptor (IL-6R) antagonists, and prior treatment with a Janus kinase inhibitor. • Current treatment with DMARDS / immunosuppressive agents including MTX, cyclosporine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine or hydroxychloroquine within 2 weeks prior to the baseline (Randomization Visit) or azathioprine, cyclophosphamide within 12 weeks prior to baseline (Randomization Visit) or leflunomide within 8 weeks prior to the Randomization Visit, or 4 weeks after standard cholestyramine washout:
Countries
Argentina, Chile, Czech Republic, Germany, Hungary, Israel, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United Kindgdom, United States
Contacts
Public ContactKatia Meza
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed