A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis

Prior treatment

• Patients who have previously received infliximab, for any purpose, cannot be enrolled.
• Patient who has previously received investigational or licensed biological disease-modifying antirheumatic drugs (bDMARDs) for the treatment of RA, who meets any of following conditions a) Patient who has previously received more than 2 investigational or licensed bDMARDs for the treatment of RA, b) Patients with history of inadequate response to tumor necrosis factor (TNF) α inhibitor (the reason for discontinuation due to lack of efficacy), c) Patients who have received a B-cell depleting agent (e.g., rituximab) for the treatment of RA, d) Patients who have not met the required washout period prior to the first administration of study drug for the bDMARD specified below, or at least five times the mean terminal elimination half-life of the drug if not specified: • ≥ 4 weeks for etanercept; • ≥ 8 weeks for adalimumab, certolizumab, golimumab, abatacept, sarilumab and tocilizumab;
• Patient who has previously received any investigational or licensed targeted synthetic DMARDs (e.g., tofacitinib, baricitinib) for the treatment of RA.

Other illness

• Patient who has allergies to any of the excipients of infliximab or any other murine and/or human proteins or patient with a hypersensitivity to immunoglobulin product.

• Patient who is male or female aged 18 to 75 years old (both inclusive).
• Patient who has a diagnosis of RA at least 24 weeks prior to the first administration of the study drug (Day 1) and fulfill the 2010 ACR/EULAR classification criteria for RA.
• Patient who has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed), 6 or more tender joints (of 68 assessed) at Screening and baseline, and either a C-reactive protein (CRP) ≥1.0 mg/dL (≥10 mg/L) (at Screening) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour (at Screening and baseline).
• Patient who has at least one of the following at Screening: a) Positive for anti-cyclic citrullinated peptide (anti-CCP); or b) Positive for rheumatoid factor (RF); or c) If both RF and anti-CCP are negative, ≥1 bone erosions of the joints on X-ray on locally read screening X-ray.
• Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 24 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 8 weeks prior to the first administration of the study drug (Day 1).