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

Trial details

Who runs it

Celltrion Inc.

Trial code

EU 2024-510945-32-00

Record updated

2026. február 5.

Original description

• To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12.Read full original descriptionShow less

• To demonstrate superiority of CT P13 SC over Placebo in terms of efficacy as determined by clinical response according to the American College of Rheumatology (ACR) definition of a 20% improvement (ACR20) at Week 12.

Inclusion: 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).

Exclusion: Patient who has previously received investigational or licensed product; biological or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or a tumor necrosis factor (TNF) α inhibitors for the any purpose; Patient who has received or has plan to receive any of following prohibited medications or treatments: a. Intra-articular corticosteroids within 4 weeks prior to the first administration of the study drug (Day 1). b. Disease-modifying antirheumatic drugs (DMARDs), other than MTX, including hydroxychloroquine, chloroquine, or sulfasalazine, within 4 weeks prior to the first administration of the study drug (Day 1). c. Alkylating agents within 12 months prior to the first administration of the study drug (Day 1) d. Live or live-attenuated vaccine within 4 weeks prior to the first administration of the study drug (Day 1), or any planned live or live-attenuated vaccination during the study period e. Any surgical procedure, including bone or joint surgery or synovectomy (including joint fusion or replacement) within 12 weeks prior to the first administration of the study drug (Day 1) or planned within 12 weeks after the first administration of the study drug (Day 1) f. Any other investigational device or medical product within 4 weeks prior to the first administration of the study drug (Day 1) or 5 half-lives, whichever is longer; 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.

EU CTIS 2024-510945-32-00