Etanercept and Methotrexate in Patients to Induce Remission in Early Arthritis (EMPIRE) (EMPIRE)

Inclusion Criteria:

• Is age 18 -80 years old
• Patients have articular synovitis, within 3 months of diagnosis
• Either RF antibody (+) or anti-CCP antibody (+) or SE (+)
• Demonstrates a negative urine pregnancy test at screening if female of childbearing potential
• Agrees to use a medically accepted form of contraception during the study and for 3 months after the last dose of study drug, if sexually active male
• Is capable of understanding and signing an informed consent form
• Is able and willing to self-inject study drug or have a designee who can do so
• Is able and willing to take oral medication
• Is able to store injectable test article at 2° C to 8° C
• Demonstrates a negative tuberculosis screening test

Exclusion Criteria:

• Received previous treatment with any DMARDS
• Received previous treatment with ETN or other tumour necrosis factor (TNF) antagonist (e.g. a TNF monoclonal antibody or a soluble TNF-receptor)
• Previous treatment with IL-1 receptor antagonist
• Chronic arthritis diagnosed before 16 years old
• Received any investigational "biological" agent within 3 months of screening visit
• Received treatment with any investigational drug of "chemical" nature within one month prior to study screening
• Known Human Immunodeficiency Virus (HIV)
• Presence of any contraindication to ETN or MTX
• Has significant concurrent medical diseases
• Has cancer or a history of cancer within 5 years of entering the screening period
• Current crystal or infective arthritis
• Chronic infection of the upper respiratory tract, chest, urinary tract or skin
• Any ongoing or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics within the preceding 30 days and/or orally administered antibiotics in the preceding 15 days
• Demonstrates liver function abnormality
• Has renal disease
• Has leukopenia
• Has thrombocytopenia
• Has a hemoglobin level of < 9g/L for males and < 85 g/L for females
• Is pregnant or breast-feeding
• Joint surgery within preceding 2 months (at joints to be assessed within this study)
• Received anti-CD4, diphtheria interleukin-2 fusion protein, anti-interleukin-6 (anti-IL-6), rituximab or other immunosuppressive biologic during the last 6 months before screening, and treatment with such agents more than 6 months before screening if there are persistent signs of immunosuppression (with a subsequent abnormal absolute T-cell count) at screening visit
• Received any live (attenuated) vaccines within 4 weeks of screening visit
• Received cyclophosphamide within 6 months of screening visit
• Any corticosteroids within 28days prior to screening
• Uses a dose of NSAID greater than the maximum recommended dose in the product information at the screening visit
• Has a history of confirmed blood dyscrasia
• Has any condition judged by the physician to cause this study to be detrimental to the subject
• Has a history of drug abuse or psychiatric disease that would interfere with the ability to comply with the study protocol
• Has a history of alcohol abuse or excessive alcohol beverage consumption
• Has a history of known liver cirrhosis, fibrosis, or fatty liver
• Has a history of any viral hepatitis within 1 year of screening