A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- American College of Rheumatology (ACR) 20% response rate
研究概览
简要总结
The purpose of this study is to compare the clinical efficacy including joint damage progression and safety of Abatacept plus Methotrexate (MTX) to placebo plus MTX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MTX inadequate responder
- •Biologic Naïve
- •Functional class I, II or III
- •≥6 swollen and ≥6 tender joints
- •C-reactive protein (CRP) ≥2.0mg/dl or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- •Anti-cyclic citrullinated peptide (CCP) antibody positive
- •Have erosion
排除标准
- •Any other rheumatic disease
- •Active angiitis on main organs excluding rheumatoid nodule
研究组 & 干预措施
Group 1: Abatacept + Methotrexate (MTX)
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
干预措施: Abatacept (Biological)
Group 1: Abatacept + Methotrexate (MTX)
Abatacept 10 mg/kg solution intravenous (IV) infusion, once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
干预措施: Methotrexate (Drug)
Group 2: Placebo matching with Abatacept + Methotrexate
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
干预措施: Placebo matching with Abatacept (Drug)
Group 2: Placebo matching with Abatacept + Methotrexate
Placebo matching with Abatacept 0 mg/kg solution, intravenous (IV) infusion once monthly for 12 months
Methotrexate ≥6 mg/week for 12 months
干预措施: Methotrexate (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20% response rate
时间窗: 4 months (week 16)
Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)
时间窗: Baseline (Day 1), 6 months (Week 24)
次要结局
- Change from baseline in Disease Activity Score-28 (DAS28)-CRP to 4 months (Week16)(Baseline (Day 1), 4 months (Week 16))
- Safety and tolerability will be measured based on clinical Adverse Events, vital signs, and laboratory abnormalities(12 months (Week52))
- ACR 70 response rates(4 months (Week16))
- Non-progressors rate for the structural damage(Baseline (Day 1), 6 months (Week 24))
- ACR 50 response rates(4 months (Week16))