NCT03274141已完成不适用
The Abatacept Best Care (ABC) Trial
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 281 人开始时间: 2011年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Number of T2T patients achieving sustained CDAI LDA
研究概览
简要总结
This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or older.
- •Active moderate to severe RA, defined as CDAI >
- •The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
- •Patient has provided a written informed consent and is able to complete the survey requirements.
- •Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.
排除标准
- •Has received abatacept (SC or IV) prior to the enrolment visit.
- •Has failed more than one prior biologic DMARD therapy
- •Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
- •Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
- •Is participating in another industry-sponsored observational study.
- •Patients participating to non-industry related registries or other data collection studies can be included
- •Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.
结局指标
主要结局
Number of T2T patients achieving sustained CDAI LDA
时间窗: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
Number of RC patients achieving sustained CDAI LDA
时间窗: Approximately 1 year
Low Disease Activity (LDA) as determined by the Clinical Disease Activity Index (CDAI) is defined as a CDAI score of less than or equal to 10.
次要结局
- Change from baseline in SDAI score(Baseline up to 24 months)
- Change from baseline in Tender Joint Count of 28 joints (TJC28) score(Baseline up to 24 months)
- Change from baseline in Patient Pain(Baseline up to 24 months)
- Number of patients achieving DAS28-CRP LDA(Up to 24 months)
- Number of changes to Rheumatoid Arthritis (RA) treatment(Up to 24 months)
- Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment(Up to 12 months)
- Number of patients achieving SDAI remission(Up to 24 months)
- Mean time for patients to achieve SDAI remission(Up to 24 months)
- Mean time for patients to achieve CDAI remission(Up to 24 months)
- Number of patients achieving RAPID3 remission(Up to 24 months)
- Change from baseline in DAS28-CRP score(Baseline up to 24 months)
- Change from baseline in CDAI score(Baseline up to 24 months)
- Change from baseline in Work Productivity and Activity Impairment (WPAI) score(Baseline up to 24 months)
- Incidence of treatment-emergent Adverse Events(Up to 24 months)
- Mean time for patients to achieve DAS28-CRP LDA(Up to 24 months)
- Number of patients achieving RAPID3 LDA(Up to 24 months)
- Mean time for patients to achieve clinically meaningful improvement(Up to 24 months)
- Number of patients achieving patient expectations for treatment of their RA(Up to 24 months)
- Number of patients achieving CDAI remission(Up to 24 months)
- Number of patients achieving Boolean remission(Up to 24 months)
- Mean time for patients to achieve Boolean remission(Up to 24 months)
- Mean time for patients to achieve RAPID3 remission(Up to 24 months)
- Number of patients achieving MCID in HAQ-DI(Up to 24 months)
- Change from baseline in HAQ-DI score(Baseline up to 24 months)
- Change from baseline in Patient Fatigue(Baseline up to 24 months)
- Time to achieve sustained CDAI LDA(Up to 12 Months)
- Number of patients achieving DAS28-CRP remission(Up to 24 months)
- Mean time for patients to achieve DAS28-CRP remission(Up to 24 months)
- Mean time for patients to achieve RAPID3 LDA(Up to 24 months)
- Mean time for patients to achieve MCID in HAQ-DI(Up to 24 months)
- Number of patients achieving clinically meaningful improvement(Up to 24 months)
- Change from baseline in RAPID3 score(Baseline up to 24 months)
- Change from baseline in Swollen Joint Count of 28 joints (SJC28) score(Baseline up to 24 months)
- Number of patients continuing treatment(At 24 months)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
3 期
A Phase 3 Study of Abatacept in Chinese Patients With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid Arthritis (RA)NCT02722694Jiangsu Simcere Pharmaceutical Co., Ltd.360
终止
2 期
Efficacy and Safety Study of Abatacept to Treat Lupus NephritisSystemic Lupus ErythematosusNCT00430677Bristol-Myers Squibb423
已完成
3 期
Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)Juvenile Idiopathic ArthritisNCT03841357Duke University121
已完成
3 期
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to MethotrexateRheumatoid ArthritisNCT00048568Bristol-Myers Squibb1,250
已完成
3 期
Study of Abatacept (BMS-188667) in Subjects With Active Rheumatoid Arthritis on Background Non-biologic DMARDS (Disease Modifying Antirheumatic Drugs) Who Have an Inadequate Response to Anti-TNF TherapyRheumatoid ArthritisNCT00124982Bristol-Myers Squibb1,286