2024-510945-32-00招募中3 期
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
Celltrion Inc., Celltrion Inc.10 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2024年12月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 189
- 试验地点
- 10
- 主要终点
- Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.
研究概览
简要总结
• 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.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Open Label Extension Period (Week 12 to Week 52[End-of-Study visit])
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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 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 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
结局指标
主要结局
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.
Proportion of patients achieving clinical response according to the ACR20 criteria at Week 12.
次要结局
未报告次要终点
研究者
Clinical Planning
Scientific
Celltrion Inc.
研究点 (10)
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