Inclusion Criteria:
- Early rheumatoid arthritis (RA), defined as symptoms of RA that started ≤ 12 months
prior to screening and satisfied the American College of Rheumatology/European League
Against Rheumatism (ACR/EULAR) 2010 criteria for the classification of RA at some
point during the 12-month period
- Naïve to any targeted (biologic or nonbiologic) disease-modifying antirheumatic drugs
(DMARDs), conventional synthetic DMARDs other than methotrexate (MTX), or
investigational therapies for RA
- Treated with MTX for at least 12 weeks, with a stable dose of oral or parenteral MTX
for at least 4 weeks prior to randomization
- Anti-cyclic citrullinated peptide-2 (Anti-CCP-2) test that is > 3× the upper limit of
normal and are positive for rheumatoid factor (RF) according to central lab testing
during screening
- At least a Disease Activity Score 28-joint count calculated using C-reactive protein
(DAS28-CRP) ≥ 3.2 at screening
- At least 3 tender and at least 3 swollen joints at screening and at randomization
Exclusion Criteria:
- Women who are breastfeeding
- Autoimmune disease other than RA (e.g., psoriasis, systemic lupus erythematosus [SLE],
vasculitis, seronegative spondyloarthritis, inflammatory bowel disease, Sjogren's
syndrome) or currently active fibromyalgia
- History of or current inflammatory joint disease other than RA (e.g., psoriatic
arthritis, gout, reactive arthritis, Lyme disease)
- At risk for tuberculosis
- Recent acute infection
- History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
osteomyelitis, bronchiectasis)
- History of infection of a joint prosthesis or artificial joint
- History of systemic fungal infections (such as histoplasmosis, blastomycosis, or
coccidiomycosis)
- History of primary immunodeficiency
- Current clinical findings or a history of a demyelinating disorder
- 5 or more joints cannot be assessed for tenderness or swelling
Other protocol-defined inclusion/exclusion criteria apply
Active, Not Recruiting
