A Randomized, Double-blind, Phase 3 Study of ABP 501 Efficacy and Safety Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 526
- 试验地点
- 12
- 主要终点
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥ 18 and ≤ 80 years old
- •Subjects must be diagnosed with rheumatoid arthritis for at least 3 months before baseline
- •Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline
- •Subjects must be taking MTX for ≥ 12 consecutive weeks and on a stable dose of 7.5 to 25 mg/week for > 8 weeks prior to receiving the study drug and be willing to remain on stable dose throughout the study
- •Subject has no known history of active tuberculosis
排除标准
- •Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
- •Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
- •Prior use of 2 or more biologic therapies for RA
- •Previous receipt of HUMIRA® (adalimumab) or a biosimilar of adalimumab
- •Ongoing use of prohibited treatments
- •Other Inclusion/Exclusion criteria may apply
结局指标
主要结局
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
时间窗: Baseline and Week 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
次要结局
- Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)(Baseline and weeks 2, 4, 8, 12, 18, and 24)
- Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab(Up to week 26)
- Percentage of Participants With an ACR70 Response at Week 24(Baseline and Week 24)
- Percentage of Participants With an ACR20 Response at Week 2 and Week 8(Baseline, week 2 and week 8)
- Number of Participants With Adverse Events(From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.)
- Percentage of Participants With an ACR50 Response at Week 24(Baseline and week 24)