Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

Inclusion Criteria

• Subject (man or woman) is ≥ 18 and ≤ 80 years old.
• Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA.
• Subject has RA duration of at least 3 months.
• Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least 1 of the following at screening:
• erythrocyte sedimentation rate ≥ 28 mm/hr
• serum C-reactive protein > 1.0 mg/dL
• Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening.
• Subject has taken methotrexate (MTX) for ≥ 12 consecutive weeks and is on a stable dose of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving the investigational product and is willing to remain on a stable dose throughout the study.
• For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be stable for ≥ 2 weeks before screening.
• For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the dose should be stable for ≥ 4 weeks before screening.
• Subject has no known history of active tuberculosis.
• Subject has a negative test for tuberculosis during screening defined as either:
• negative purified protein derivative (PPD) defined as < 5 mm of induration at 48 to 72 hours after test is placed OR
• negative Quantiferon test
• Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test.
• Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following:
• no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc.
• documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations
• no known exposure to a case of active tuberculosis after most recent prophylaxis

Exclusion Criteria

• Subject has a history of prosthetic or native joint infection.
• Subject has an active infection or history of infections as follows:
• any active infection for which systemic anti-infectives were used within 28 days before first dose of investigational product
• a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infective(s) within 8 weeks before the first dose of investigational product
• recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject
• Subject has a positive blood test for human immunodeficiency virus (HIV).
• Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening.
• Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate or severe heart failure (New York Heart Association Class III/IV), renal disease, liver disease, or hypertension.
• Subject had a malignancy within 5 years EXCEPT for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma.
• Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease.
• Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome.
• Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject.
• Subject has laboratory abnormalities at screening, including any of the following:
• hem