Switching Anti-TNF-Alpha Agents in Rheumatoid Arthritis (RA)

Inclusion Criteria

• •Diagnosis of Rheumatoid Arthritis
• •Current treatment with either etanercept or adalimumab for at least 12 weeks prior to randomization
• •Disease Activity Score (DAS) C-reactive Protein (CRP) 28 ≥ 4.4
• •Treatment with concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs) is permitted but not required as described below:
• •1. Methotrexate - maximum dose of 25 mg per os (PO), intra-muscular (IM), or SQ weekly.
• •2. Leflunomide - maximum dose of 20 mg PO daily.
• •3. Sulfasalazine - maximum dose of 1,500 mg PO twice daily.
• •4. Hydroxychloroquine - maximum dose of 400 mg PO daily.
• •If taking DMARD(s), subjects must be on stable doses for at least 12 weeks prior to randomization.
• •If treated with prednisone (or equivalent corticosteroid), on a stable dose of \<= 10 mg/day for 28 days prior to randomization.
• •Agree to use appropriate form of contraception. More information on this criterion can be found in the protocol.
• •Concurrent use of any biologic agent other than etanercept or adalimumab
• •Concomitant immunosuppressive therapy other than the Disease-Modifying Anti-Rheumatic Drugs (DMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), or corticosteroids specified in the protocol
• •Presence of open leg ulcers
• •Chronic or persistent infection that may be worsened by immunosuppressive treatment. More information on this criterion can be found in the protocol.
• •Active infection or severe infections requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 30 days prior to randomization
• •History of positive Purified Protein Derivative (PPD) or chest x-ray findings indicative of prior tuberculosis infection
• •Any medical condition or treatment that, in the opinion of the investigator, would put the subject at risk by participation in the study
• •History of malignancy. More information on this criterion can be found in the protocol.
• •Certain abnormal laboratory values. More information on this criterion can be found in the protocol.
• •Investigational biological or chemical agents within 4 weeks prior to randomization.
• •History of drug or alcohol abuse within a year prior to randomization
• •Treatment with natalizumab, rituximab, or another B-cell depleting therapy within a year prior to randomization
• •Treatment with infliximab, abatacept, tocilizumab, golimumab, or certolizumab pegol within 12 weeks prior to randomization.
• •Known allergy or hypersensitivity to study products
• •Any psychiatric disorder that prevents the participant from providing informed consent
• •Inability to follow protocol instructions
• •Pregnant or breastfeeding