Switching Anti-TNF-alpha Agents in Patients With RA With An Inadequate Response to TNF-alpha Inhibition

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.

Exclusion Criteria:

- Diagnosis of another autoimmune disease likely to require immunosuppression. More
information on this criterion can be found in the protocol.

- Failing treatment with etanercept if previously treated with adalimumab

- Failing treatment with adalimumab if previously treated with etanercept

- Intraarticular injection within 4 weeks prior to randomization

- Concomitant use of DMARDs other than those described in Inclusion Criteria within 12
weeks of randomization.

- 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