A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis

Inclusion Criteria

• Male or non-pregnant, non-nursing female
• Age 18 years or greater
• Body weight less than or equal to 120 kg
• Classification of Rheumatoid Arthritis according to the 1987 ACR criteria or 2010 ACR/EULAR criteria
• Symptoms of Rheumatoid Arthritis present for at least 3 months and less that 10 years prior to Screening.
• Clinical Disease Activity Index (CDAI) greater than or equal to 16, corresponding to moderate to severe disease activity.
• Patients taking oral DMARDs must be on stable doses of DMARDs for at least 4 weeks prior to Abatacept initiation
• Treatment within the past year with either methotrexate, leflunomide, hydroxychloroquine and/or sulfasalazine for greater than or equal to 8 weeks.
• Patients who have received one prior Tumor necrosis factor (TNF) inhibitor must have discontinued etanercept, infliximab, adalimumab, certolizumab, or golimumab for at least 6 months prior to screening.
• Patients taking oral corticosteroids, the dose must be less than or equal to 5mg per day (prednisone or equivalent)
• Females of child bearing potential and males with female partners of child bearing potential may participate in this study only if using a reliable means of contraception

Exclusion Criteria

• Previous treatment with Abatacept (Orencia)
• Previous treatment with rituximab, tocilizumab, tofacitinib, sarilumab, or anakinra
• Previous treatment with IV immunoglobulin, plasmapheresis, or alkylating agents such as cyclophosphamide
• Intraarticular or parenteral corticosteroids within 4 weeks of screening
• Rheumatic autoimmune disease other than Rheumatoid Arthritis, including Systemic Lupus Erythematosus, primary Sjogren syndrome, spondyloarthritis, systemic sclerosis, dermatomyositis, mixed connective tissue disease, or vasculitis
• Non-rheumatic auto-immune disease including inflammatory bowel disease, psoriasis, multiple sclerosis
• Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, latent tuberculosis (TB) (TB not adequately treated)
• Primary or secondary immunodeficiency
• Current, uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease
• History of malignancy within 10 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma
• History of alcohol, drug, or chemical abuse within 1 year prior to screening
• Laboratory exclusion criteria at screening including:
• estimated glomerular filtration rate (eGFR) 1.5 times upper limit of normal
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
• Immunization with a live/attenuated vaccine within 4 weeks prior to screening
• Pregnant or nursing women, or women of child bearing potential who plan to become pregnant prior to 14 weeks after the last dose of abatacept treatment
• Patients of reproductive potential not willing to use an effective method of contraception
• Prisoners, or subjects who are compulsory detained