An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy
2016年7月6日 更新者：Hoffmann-La Roche
A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy.
Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy.
Data will be collected for 12 months.
研究概览
研究类型
观察性的
注册 (实际的)
90
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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Busan、大韩民国、48108
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Daegu、大韩民国、41931
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Daegu、大韩民国、42472
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Daejeon、大韩民国、302-799
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Gwangju、大韩民国、61469
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Gyeonggi-do、大韩民国、10380
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Jeju Special Self-Governing Province、大韩民国、63241
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Jeollabuk-do、大韩民国、561-712
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Seoul、大韩民国、150-713
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Seoul、大韩民国、130-702
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Seoul、大韩民国、05030
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Seoul、大韩民国、06273
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Seoul、大韩民国、134-722
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Suwon、大韩民国、442-723
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Ulsan、大韩民国、44033
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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
概率样本
研究人群
Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.
描述
Inclusion Criteria:
- Adult participants, >/=20 years of age
- Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion Criteria:
- Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
- Participants who have not signed the informed consent form
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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Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
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Rituximab as per physician's discretion.
其他名称：
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Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
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Adalimumab as per physician's discretion.
Etanercept as per physician's discretion.
Infliximab as per physician's discretion.
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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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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
大体时间：Baseline and Month 6
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DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
大体时间：Baseline and Month 6
|
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 6
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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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Efficacy: Mean Change From Baseline in DAS28 at Month 12
大体时间：Baseline and Month 12
|
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity.
A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
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Baseline and Month 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
大体时间：Baseline, Month 6 and 12
|
TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
大体时间：Baseline, Month 6 and 12
|
TJC is a clinical method to quantify abnormalities in participants with RA.
It is associated with the level of pain.
The number of tender joints were scored as tender=1 and not tender=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of tender joints).
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Baseline, Month 6 and 12
|
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
大体时间：Baseline, Month 6 and 12
|
SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
|
Baseline, Month 6 and 12
|
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Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
大体时间：Baseline, Month 6 and 12
|
SJC is a clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
The number of swollen joints were scored as swollen=1 and not swollen=0, and counted.
A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
大体时间：Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
大体时间：Baseline, Month 6 and 12
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ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
大体时间：Baseline, Month 6 and 12
|
CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
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Baseline, Month 6 and 12
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Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
大体时间：Baseline, Month 6 and 12
|
CRP is an inflammation marker.
High levels of this protein indicate inflammation in diseases such as RA.
A negative change from baseline represents a reduction in inflammation.
|
Baseline, Month 6 and 12
|
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
大体时间：Month 6
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The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
|
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Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
大体时间：Month 6
|
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis.
It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.
Each domain has at least two component questions.
There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).
The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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Month 6
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Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
大体时间：Baseline up to Month 12
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An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties.
A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
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Baseline up to Month 12
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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。
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
2011年11月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2012年4月11日
首先提交符合 QC 标准的
2012年5月3日
首次发布 (估计)
2012年5月7日
研究记录更新
最后更新发布 (估计)
2016年8月22日
上次提交的符合 QC 标准的更新
2016年7月6日
最后验证
2016年3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.