PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis

Inclusion Criteria

• Patient is male or female between 18 and 75 years old, inclusive.
• Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization.
• Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour.
• Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab
• Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept.

Exclusion Criteria

• Patient has taken more than 2 biologic agents.
• Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study.
• Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins.
• Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections.
• Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.