Arthritis Clinical Trials

Inclusion Criteria:

• Male or non-pregnant, non-lactating female patients
• Presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
• At Baseline: Disease activity criteria defined by >= 6 tender joints out of 68 and >= 6 swollen joints out of 66

WITH at least 1 of the following at screening:

• Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibodies positive OR
• Rheumatoid Factor positive

AND WITH at least 1 of the following at screening:

• High sensitivity C-Reactive Protein (hsCRP) >= 10 mg/L OR
• Erythrocyte Sedimentation Rate (ESR) >= 28 millimeter (mm)/1st hour
• Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
• Patients must be taking MTX or any other DMARD (but not more than 1 DMARD) for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week for MTX or other DMARD at maximum tolerated dose)

Exclusion Criteria:

• Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
• RA patients functional status class IV according to the ACR 1991 revised criteria
• Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
• Previous treatment with any cell-depleting therapies

Other protocol-defined inclusion/exclusion criteria may apply.