Efficacy and Safety of Olokizumab With Rheumatoid Arthritis With Previously Failed to Anti-tumor Necrosis Factor (Anti-TNF) Therapy

Inclusion criteria

• Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
• Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR >28mm/hour
• Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
• Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
• Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception

Exclusion criteria

• Have a diagnosis of any other inflammatory arthritis
• Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
• Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
• Subjects with known concurrent acute or chronic viral hepatitis B or C infection
• Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
• Subjects with known history of or current clinically active infection
• Subjects at high risk of infection
• Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
• Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
• Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening