Comparing 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) (ABC)
2019年1月28日 更新者：Bristol-Myers Squibb
The Abatacept Best Care (ABC) Trial
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.
研究概览
研究类型
观察性的
注册 (实际的)
281
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Westmount、Quebec、加拿大、H3Z 1R7
- Local Institution
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult patients with active RA defined as a CDAI > 10 for whom the treating physician has made the decision to initiate treatment with SC abatacept according to the approved Canadian product monograph and regional reimbursement criteria will be potentially eligible for inclusion in the study.
The decision to treat the patient with SC abatacept must have been reached prior to and independently of considering the patient for study enrollment.
描述
Inclusion Criteria:
- 18 years of age or older.
- Active moderate to severe RA, defined as CDAI > 10.
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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T2T Patients
RA patients managed with a treat-to-target (T2T) strategy
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非介入式
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RC Patients
RA patients managed with routine care(RC)
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非介入式
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of T2T patients achieving sustained CDAI LDA
大体时间：Approximately 1 year
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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.
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Approximately 1 year
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Number of RC patients achieving sustained CDAI LDA
大体时间：Approximately 1 year
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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.
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Approximately 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of patients achieving SDAI remission
大体时间：Up to 24 months
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Simplified Disease Activity Index (SDAI) remission is achieved when SDAI score is less than or equal to 3.3
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Up to 24 months
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Mean time for patients to achieve SDAI remission
大体时间：Up to 24 months
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Length of time from treatment initiation SDAI remission
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Up to 24 months
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Number of patients achieving CDAI remission
大体时间：Up to 24 months
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Clinical Disease Activity Index (CDAI) remission is achieved when CDAI score is less than or equal to 2.8
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Up to 24 months
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Mean time for patients to achieve CDAI remission
大体时间：Up to 24 months
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Length of time from treatment initiation CDAI remission
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Up to 24 months
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Number of patients achieving DAS28-CRP LDA
大体时间：Up to 24 months
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Disease Activity Score (DAS) Low Disease Activity (LDA) is achieved when DAS28-CRP score is less than 3.2
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Up to 24 months
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Mean time for patients to achieve DAS28-CRP LDA
大体时间：Up to 24 months
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Length of time from treatment initiation to a DAS28-CRP score of less than 3.2
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Up to 24 months
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Number of patients achieving DAS28-CRP remission
大体时间：Up to 24 months
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Disease Activity Score (DAS) remission is achieved when DAS28-CRP score is less than 2.6
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Up to 24 months
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Mean time for patients to achieve DAS28-CRP remission
大体时间：Up to 24 months
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Length of time from treatment initiation to a DAS28-CRP score of less than 2.6
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Up to 24 months
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Number of patients achieving Boolean remission
大体时间：Up to 24 months
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Boolean remission is defined as TJC28 ≤1 and SJC28 ≤1 and CRP ≤1 mg/dl and PtGA ≤1 (on a 0-10 scale)
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Up to 24 months
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Mean time for patients to achieve Boolean remission
大体时间：Up to 24 months
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Length of time from treatment initiation to Boolean remission.
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Up to 24 months
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Number of patients achieving RAPID3 LDA
大体时间：Up to 24 months
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Routine Assessment of Patient Index Data 3 (RAPID3) Low Disease Activity (LDA) is achieved when RAPID3 score is less than or equal to 6.
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Up to 24 months
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Mean time for patients to achieve RAPID3 LDA
大体时间：Up to 24 months
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Length of time from treatment initiation to a RAPID3 score of less than or equal to 6
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Up to 24 months
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Number of patients achieving RAPID3 remission
大体时间：Up to 24 months
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Routine Assessment of Patient Index Data 3 (RAPID3) remission is achieved when RAPID3 score is less than or equal to 3.
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Up to 24 months
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Mean time for patients to achieve RAPID3 remission
大体时间：Up to 24 months
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Length of time from treatment initiation to a RAPID3 score of less than or equal to 3
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Up to 24 months
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Number of patients achieving MCID in HAQ-DI
大体时间：Up to 24 months
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minimal clinically important difference (MCID; Δ ≥ 0.22, ≥0.25, and ≥0.5) in Health Assessment Questionnaire Disability Index (HAQ-DI)
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Up to 24 months
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Mean time for patients to achieve MCID in HAQ-DI
大体时间：Up to 24 months
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Length of time from treatment initiation to a Δ ≥ 0.22, ≥0.25, and ≥0.5 in HAQ-DI
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Up to 24 months
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Number of patients achieving clinically meaningful improvement
大体时间：Up to 24 months
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Number of patients achieving clinically meaningful improvement as measured by a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
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Up to 24 months
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Mean time for patients to achieve clinically meaningful improvement
大体时间：Up to 24 months
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Length of time from treatment initiation to a decrease in CDAI of ≥ 20 or DAS28-CRP ≥ 1.2
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Up to 24 months
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Number of patients achieving patient expectations for treatment of their RA
大体时间：Up to 24 months
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Assessed using simple Visual Analogue Scales (VAS)
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Up to 24 months
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Change from baseline in DAS28-CRP score
大体时间：Baseline up to 24 months
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Measured by investigator assessment
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Baseline up to 24 months
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Change from baseline in CDAI score
大体时间：Baseline up to 24 months
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Measured by investigator assessment
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Baseline up to 24 months
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Change from baseline in SDAI score
大体时间：Baseline up to 24 months
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Measured by investigator assessment
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Baseline up to 24 months
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Change from baseline in RAPID3 score
大体时间：Baseline up to 24 months
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Measured by investigator assessment
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Baseline up to 24 months
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Change from baseline in Tender Joint Count of 28 joints (TJC28) score
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Change from baseline in Swollen Joint Count of 28 joints (SJC28) score
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Change from baseline in HAQ-DI score
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Change from baseline in Work Productivity and Activity Impairment (WPAI) score
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Change from baseline in Patient Pain
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Change from baseline in Patient Fatigue
大体时间：Baseline up to 24 months
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Measured by patient assessment
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Baseline up to 24 months
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Number of patients continuing treatment
大体时间：At 12 months
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Measured by investigator assessment
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At 12 months
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Number of patients continuing treatment
大体时间：At 24 months
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Measured by investigator assessment
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At 24 months
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Number of changes to Rheumatoid Arthritis (RA) treatment
大体时间：Up to 24 months
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Measured by investigator assessment
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Up to 24 months
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Distribution of reasons for changes to Rheumatoid Arthritis (RA) treatment
大体时间：Up to 12 months
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Measured by questionnaire
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Up to 12 months
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Incidence of treatment-emergent Adverse Events
大体时间：Up to 24 months
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Measured by investigator assessment
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Up to 24 months
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Time to achieve sustained CDAI LDA
大体时间：Up to 12 Months
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Time to achieve sustained Clinical Disease Activity Index (CDAI) Low Disease Activity (LDA)
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Up to 12 Months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2011年10月31日
初级完成 (实际的)
2018年10月31日
研究完成 (实际的)
2018年10月31日
研究注册日期
首次提交
2017年9月5日
首先提交符合 QC 标准的
2017年9月5日
首次发布 (实际的)
2017年9月6日
研究记录更新
最后更新发布 (实际的)
2019年1月30日
上次提交的符合 QC 标准的更新
2019年1月28日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
非介入式的临床试验
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Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
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Charite University, Berlin, Germany招聘中