Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries
2017年6月14日 更新者：Bristol-Myers Squibb
Evaluation of the Effectiveness of the Abatacept (Orencia®) IV and SC Patient Alert Cards in Patients With Rheumatoid Arthritis in European Economic Area Countries
The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.
研究概览
地位
完全的
条件
详细说明
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
研究类型
观察性的
注册 (实际的)
203
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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Bad Kreuznach、德国、55543
- Acura Kliniken
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Bad Kreuznach、德国、55543
- Local Institution
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Bad Nauheim、德国、61231
- Local Institution
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Bad Nauheim、德国、61231
- Bad Nauheim
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Frankenberg、德国、9669
- Local Institution
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Heidelberg、德国、69120
- Universitätsklinikum Heidelberg
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Heidelberg、德国、69120
- Local Institution
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Heidelberg、德国、69121
- Heidelberg
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Zwickau、德国、8056
- Local Institution
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Zwickau、德国、8056
- Zwickau
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Limoges、法国、87042
- CHU Limoges - Hopital Dupuytren
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Paris、法国、75571
- APHM - Hopital Sainte-Marguerite, Marseille
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Malmö、瑞典、20502
- Local Institution
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Solna、瑞典、17176
- Local Institution
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Abergavenny、英国、NP7 7EG
- Nevil Hall Hospital
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Basingstoke、英国、RG24 9NA
- Local Institution
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Derby、英国、DE22 3NE
- Royal Derby Hospital
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Dewsbury、英国、WF13 4HS
- Barnsley Hospital NHS Foundation Trust
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East Sussex、英国、BN21 2UD
- Eastbourne District Gen. Hosp.
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Harlow、英国、CM20 1QX
- Princess Alexandra Hospital
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Harlow、英国、CM20 1QX
- Local Institution
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St. Helens、英国、WA9 3DA
- St Helens Hospital
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Wirral、英国、CH49 5PE
- Arrow Park Hospital
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A Coruña、西班牙、15006
- Hospital Coruña
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Barbastro、西班牙、22300
- Hospital Ccal. de Barbastro
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Elche、西班牙、3203
- Hospital Elche
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Elda、西班牙、3600
- Hospital Elda
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Elda、西班牙、3600
- Local Institution
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Getafe、西班牙、28905
- Hospital Getafe
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Madrid、西班牙、28007
- Hospital Gregorio Marañón
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Madrid、西班牙、28007
- Local Institution
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Merida、西班牙、6800
- Hospital Merida
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Plasencia、西班牙、10600
- Hospital Virgen del Puerto
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Plasencia、西班牙、10600
- Local Institution
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Sevilla、西班牙、41009
- Hospital Virgen Macarena
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Terrasa、西班牙、8221
- Hospital Mutua de Terrasa
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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
概率样本
研究人群
Cohort 1: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices
Cohort 2: Physician or nurse based in hospital RA department and physician clinics and offices
Cohort 3: Patients enrolled by physician or nurse based in hospital rheumatology departments and physician clinics and offices
描述
Inclusion Criteria:
Patient survey (cohort 1):
- Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
- Patient is 18 years of age or over
HCP survey (cohort 2):
a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up)
Retrospective chart review study (cohort 3):
- Patient survey questionnaire completed , Informed Consent Form (ICF) signed
Exclusion Criteria:
Patient survey:
- Patient has participated in a clinical trial for their arthritis in the previous 12 months
- Currently an employee of BMS
HCP survey:
- Physicians or nurse who have recruited patients for the Patient survey
- Currently an employee of BMS
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 |
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Patients survey
Adult patients treated with abatacept for rheumatoid arthritis
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HCP survey
HCP with at least 1 patient taking abatacept
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Retrospective chart review study
Adult patients treated with abatacept for rheumatoid arthritis
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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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Patient survey: Proportion of patients treated with abatacept who are aware of the existence of the PAC
大体时间：At patient enrolment
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At patient enrolment
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Patient survey: Proportion of patients treated with abatacept who have received the PAC
大体时间：At patient enrolment
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At patient enrolment
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Patient survey: Proportion of patients who have utilised the PAC, and the extent of its use
大体时间：At patient enrolment
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At patient enrolment
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Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of allergic reactions associated with abatacept treatment
大体时间：At patient enrolment
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At patient enrolment
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Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of associated with abatacept treatment
大体时间：At patient enrolment
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At patient enrolment
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Patient survey: Mean scores for correct responses for questions grouped by objectives
大体时间：At patient enrolment
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Objectives: distribution, awareness, utility, utilization and knowledge
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At patient enrolment
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Patient survey: Mean total score for correct responses
大体时间：At patient enrolment
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At patient enrolment
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HCP survey: Proportion of HCPs who prescribe or administer abatacept in rheumatology centers who are aware of the PAC
大体时间：Day 1
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Day 1
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HCP survey: Proportion of HCPs' who have utilized the PAC, and the extent of its use
大体时间：Day 1
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Day 1
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HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering abatacept
大体时间：Day 1
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Day 1
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HCP survey: Mean total score for correct responses
大体时间：Day 1
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Day 1
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HCP survey: Mean scores for correct responses for questions grouped by objectives
大体时间：Day 1
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Objectives: distribution, awareness, utility, utilization and knowledge
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Day 1
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Retrospective chart review study (clinical outcome study): Proportion of infections leading to hospitalization
大体时间：Approximately 3 months
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Approximately 3 months
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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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Major determinants of patients knowledge of the key messages contained in the abatacept IV, Subcutaneous (SC) formulation PACs among patients
大体时间：At patient enrolment
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Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration |
At patient enrolment
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Major determinants of understanding the key messages contained in the abatacept IV, SC formulation PACs among patients
大体时间：At patient enrolment
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Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration |
At patient enrolment
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Major determinants of implementation regarding the key messages contained in the abatacept IV, SC formulation PACs among patients
大体时间：At patient enrolment
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Determinants: Formulation of abatacept administered, country, age, gender, educational level, duration of arthritis, number of prescription medications, duration of therapy with abatacept, HCP guided or self-administration |
At patient enrolment
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Determinants of Health Care Professional (HCP) understanding, Implementation regarding key messages contained in the PAC based on data collected in the abatacept IV and SC formulation PACs among HCPs
大体时间：Day 1
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Determinants: type of HCP, role of the HCP, country, age and sex of the HCP, years in the specialty, number of HCPs in the unit, annual number of patients managed by the unit, number of patients for whom abatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town
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Day 1
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Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for Tuberculosis (TB) prior to administration of therapy of abatacept
大体时间：Upto 8 years
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Upto 8 years
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Retrospective chart review study (clinical outcome study): Proportion of patients with results of any test to screen for viral hepatitis before administration of therapy with abatacept
大体时间：Upto 8 years
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Upto 8 years
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Retrospective chart review study (clinical outcome study): Mean time from infection (symptom onset) to receiving medical attention
大体时间：Upto 8 years
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Upto 8 years
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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)
2016年11月29日
初级完成 (实际的)
2017年4月28日
研究完成 (实际的)
2017年4月28日
研究注册日期
首次提交
2015年12月10日
首先提交符合 QC 标准的
2015年12月14日
首次发布 (估计)
2015年12月17日
研究记录更新
最后更新发布 (实际的)
2017年6月16日
上次提交的符合 QC 标准的更新
2017年6月14日
最后验证
2017年6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.