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

You may be able to join if

• 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. Note. Medical records or sufficient documentation supporting RA diagnosis based on the 2010 ACR/EULAR classification criteria must be available in the source documents.
• 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), and either a high-sensitivity C-reactive protein (hsCRP) ≥1.0 mg/dL (≥10 mg/L) or an erythrocyte sedimentation rate (ESR) ≥28 mm/hour at Screening.
• Patient who has been receiving the treatment of oral or parenteral dosing with MTX for at least 12 weeks and has been on stable dosing with MTX between 10 to 25 mg/week for at least 4 weeks prior to the first administration of the study drug (Day 1).
• Patient who has adequate renal and hepatic function at Screening as defined by the following clinical chemistry results: a. Serum creatinine <1.5 × upper limit of normal (ULN) or an estimated creatinine clearance level >50 mL/min (by Cockcroft-Gault formula) (SI [International System of Units] units: 0.84mL/s) b. Serum alanine aminotransferase (ALT) <2.5 × ULN c. Serum aspartate aminotransferase (AST) <2.5 × ULN d. Serum total bilirubin <2 × ULN
• Patient who has the following hematology laboratory test results at Screening: a. Hemoglobin ≥8.5 g/dL (SI units: ≥85 g/L or 5.28 mmol/L) b. White blood cell count ≥3.5 × 10^3 cells/µL (SI units: ≥3.5 × 10^9 cells/L) c. Neutrophil count ≥1.5 × 10^3 cells/µL (SI units: ≥1.5 × 10^9 cells/L) d. Platelet count ≥100 × 10^3 cells/µL (SI units: ≥100 × 10^9 cells/L)