A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 27
- 主要终点
- Percentage of Participants With an Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •Symptoms of RA for no more than 12 months prior to enrollment
- •Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA
- •Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX < 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses
- •At least 3 tender & 3 swollen joints
- •Anti-cyclic citrullinated peptide (CCP) > 3X the upper limit of normal and positive rheumatoid factor
排除标准
- •History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc)
- •Prior use of non-biologic therapy other than methotrexate
- •Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy
- •Subjects with chronic or recent acute serious infection
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Treatment A
Abatacept Single Blind Treatment Period
干预措施: Methotrexate (Drug)
Treatment B
Adalimumab Single Blind Treatment Period
干预措施: Abatacept (Drug)
Treatment B
Adalimumab Single Blind Treatment Period
干预措施: Adalimumab (Drug)
Treatment A
Abatacept Single Blind Treatment Period
干预措施: Abatacept (Drug)
Treatment B
Adalimumab Single Blind Treatment Period
干预措施: Methotrexate (Drug)
Treatment C
Abatacept Cumulative Treatment Period
干预措施: Abatacept (Drug)
结局指标
主要结局
Percentage of Participants With an Serious Adverse Events (SAEs)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an SAEs
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (AEsDc)
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRAEs
Percentage of Drug Related Serious Adverse Events (DRSAEs)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an DRSAEs
Number of Deaths
时间窗: up to 85 days post last dose, approximately 40 weeks
Number of participants who experienced Death
Percentage of Adverse Events (AEs)
时间窗: up to 85 days post last dose, approximately 40 weeks
Percentage of participants who experienced an AE
次要结局
未报告次要终点