Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Open-label, Multi-center Observational Study in Taiwan
2022年1月6日 更新者：Bristol-Myers Squibb
Real World Effectiveness of Abatacept in Rheumatoid Arthritis Patients: a Prospective, Single-arm, Multi-center Observational Study in Taiwan
Abatacept Registry in Taiwan
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
213
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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-
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Taipei、台湾、105
- 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
20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
Hospital : Research based hospital centers, Teaching hospitals affiliated with medical schools, National/Regional medical centers and/or in which thought leaders are employed
描述
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- ≥ 20 years of age
- Who give informed consent
- Confirmed diagnosis of RA (as defined by American College of Rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment
- Who self-pay or who are reimbursed by BNHI for abatacept treatment
- With latent TB or who are receiving anti-TB treatment (INH 300 mg, QD) 1 month prior to using abatacept and continuously up to a total of 9 months Willing to follow Taiwan Risk Management Plan guidelines as required by Taiwan health authorities
- Are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy
Exclusion Criteria:
- Pregnant or breast feeding
- With active TB
- HBsAg (+)and/or Anti-HCV(+) and/or HBV DNA(+)
- Have cancer (patients who were treated and have no sign of cancer for > 10 years can be included)
- Are allergic to abatacept
- Enrolled in other RA clinical studies
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
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
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Patients treating with Abatacept
Patients who are abatacept naive and are initiating abatacept treatment (either IV or SC) including those that are switching from another bDMARD, as well as, patients currently being treated with IV or SC abatacept some of which may have switched from IV abatacept to SC abatacept
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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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The retention rate of abatacept therapy over 24 months in RA patients under real world clinical practice in Taiwan.
大体时间：approximately 24 months
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Treatment retention rate is defined as the proportion of subjects who use abatacept for 24 months
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approximately 24 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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The retention rate (%) of abatacept therapy at 6, 9, 12, and 18 months in RA patients
大体时间：at 6, 9, 12, 18, and 24months after study participation
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at 6, 9, 12, 18, and 24months after study participation
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The time to treatment discontinuation in RA patients treated with abatacept
大体时间：at 6, 9, 12, 18, and 24months after study participation
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Treatment discontinuation is defined as patients who cease treatment for > 8 weeks
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at 6, 9, 12, 18, and 24months after study participation
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The proportion of patients achieving DAS28 ≤ 2.6, 2.6 < DAS28 ≤ 3.2, 3.2 < DAS28 ≤ 5.1, DAS> 5.1 at 6, 9, 12, 18, and 24months
大体时间：at 6, 9, 12, 18, and 24months after study participation
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at 6, 9, 12, 18, and 24months after study participation
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The major reason for treatment discontinuation (eg, lack of efficacy, severe adverse drug reactions, switch from abatacept to another RA medication, financial issues, etc) at 6, 9, 12, 18, and 24 months
大体时间：at 6, 9, 12, 18, and 24months after study participation
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at 6, 9, 12, 18, and 24months after study participation
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The demographic, clinical presentation, and disease management a composite measure of RA patients who are using abatacept (either formulation) or are abatacept naïve at Month 6, 9, 12, 18, and 24
大体时间：at 6, 9, 12, 18, and 24months after study participation
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at 6, 9, 12, 18, and 24months after study participation
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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)
2014年8月6日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2015年1月7日
首先提交符合 QC 标准的
2015年1月7日
首次发布 (估计)
2015年1月12日
研究记录更新
最后更新发布 (实际的)
2022年1月21日
上次提交的符合 QC 标准的更新
2022年1月6日
最后验证
2022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.