An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety and Efficacy of ABP 501 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
- 467
- 试验地点
- 77
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
The purpose of this open-label study is to evaluate the long-term safety and efficacy of ABP 501 in adults with moderate to severe rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject was randomized into protocol 20120262 (NCT01970475) and completed the week 26 visit
排除标准
- •Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that could cause extension treatment to be detrimental
- •Subject completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262
- •Current infection requiring the use of oral or intravenous antibiotics
- •Other Inclusion/Exclusion criteria may apply
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Number of Participants With Grade ≥ 3 Hematology and Chemistry Laboratory Results
时间窗: From the first dose of study drug in the extension study to 28 days following the last dose; 72 weeks
Laboratory results were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal.
Percentage of Participants Who Developed Antibodies to ABP 501
时间窗: Up to week 72
Two validated assays were used to detect the presence of anti-drug antibodies. All samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies against ABP 501 (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501. If a sample was positive for binding antibodies and demonstrated neutralizing activity at the same time point, the sample was defined as positive for neutralizing antibodies. Preexisting antibody positive indicates participants with a positive result at baseline of the extension study. Developing antibody positive indicates participants with a negative or no result at baseline of the extension study who were positive at any time point post-baseline during the extension study.
次要结局
- Percentage of Participants With an American College of Rheumatology (ACR) 20 Response(Parent study baseline, extension study baseline and weeks 4, 24, 48, and 70)
- Change From Parent Study Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)(Parent study baseline, extension study baseline and weeks 4, 24, 48 and 70)