A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 869
- 试验地点
- 64
- 主要终点
- The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population
研究概览
简要总结
The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
- •Methotrexate failure
- •Naive to RA biologics
- •≤5 years duration of disease
- •Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
- •Willingness to self-inject subcutaneous (SC) drug
排除标准
- •Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
- •History of active or chronic hepatitis
- •Cancer in the last 5 years
- •History of severe chronic or recurrent bacterial or viral infections
- •Risk of tuberculosis
- •Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease
研究组 & 干预措施
Abatacept
干预措施: Abatacept (Drug)
Adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population
时间窗: Day 1 to Day 365
Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have \>=20% fewer tender joints and \>=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.
次要结局
- Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population(Day 1 to 12 Months)
- Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population(Day 1 to Day 729)
- Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population(Baseline to Day 729)
- Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population(Day 1 to Day 365)
- Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population(Day 1 to Day 729)
- Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population(Day 1 to Day 729)