A Retrospective Chart Review of MabThera (Rituximab) Treatment in Rheumatoid Arthritis (RA) Participants in Australia
2016年11月1日 更新者：Hoffmann-La Roche
A Retrospective Chart Review of the Use of MabThera (Rituximab) for the Treatment of Rheumatoid Arthritis (RA) in Australian Rheumatology Practice
This is a cross-sectional, observational study examining the factors leading to the therapeutic decision to use MabThera (rituximab) in participants with RA.
Routine rheumatology clinical practice data of participants who are being or have been treated with rituximab for RA will be collected and analysed in this chart review.
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
167
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
-
-
Victoria
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Geelong、Victoria、澳大利亚、3220
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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
Rheumatoid arthritis (RA) participants who have been treated with rituximab
描述
Inclusion Criteria:
- Greater than or equal to (>=) 18 years of age at the time of data collection
- RA diagnosed by a rheumatologist
- Treatment with rituximab for RA
Exclusion Criteria:
- Participants whose primary diagnosis and indication for rituximab treatment is a condition other than RA
- Participants who have been treated with an experimental agent for RA which is not currently approved for the treatment of RA in Australia
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 |
|---|
|
Rheumatoid arthritis (RA) participants
Participants who had been treated with rituximab for RA are reviewed retrospectively using chart review from Baseline until and their most recent visit to the rheumatologist prior to the conduct of the chart review.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Factors leading to Therapeutic decision to use rituximab
大体时间：Up to end of study (approximately 1 month)
|
Up to end of study (approximately 1 month)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change in Erythrocyte sedimentation rate
大体时间：Baseline and most recent visits (approximately 1 month)
|
Baseline and most recent visits (approximately 1 month)
|
|
Change in Immunoglobulin levels
大体时间：Baseline and most recent visits (approximately 1 month)
|
Baseline and most recent visits (approximately 1 month)
|
|
Percentage of participants with positive or negative results for rheumatoid factor
大体时间：Up to end of study (approximately 1 month)
|
Up to end of study (approximately 1 month)
|
|
Percentage of participants with positive or negative results for anti-cyclic citrullinated peptide antibody
大体时间：Up to end of study (approximately 1 month)
|
Up to end of study (approximately 1 month)
|
|
Percentage of participants with positive or negative results for anti-nuclear antibodies
大体时间：Up to end of study (approximately 1 month)
|
Up to end of study (approximately 1 month)
|
|
Disease activity score (DAS28)
大体时间：At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
|
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
|
|
Tender joint count (TJC)
大体时间：At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
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At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
|
|
Swollen joint count (SJC)
大体时间：At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
|
At baseline visit (most recent visit prior to MabThera treatment) and at most recent visit prior to chart review (approximately 1 month)
|
|
Duration of treatment with rituximab
大体时间：From first dose to most recent rituximab infusion (approximately 1 month)
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From first dose to most recent rituximab infusion (approximately 1 month)
|
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Change in C-reactive protein
大体时间：Baseline and most recent visits (approximately 1 month)
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Baseline and most recent visits (approximately 1 month)
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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
2012年1月1日
初级完成 (实际的)
2012年2月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2015年8月11日
首先提交符合 QC 标准的
2015年9月29日
首次发布 (估计)
2015年10月1日
研究记录更新
最后更新发布 (估计)
2016年11月2日
上次提交的符合 QC 标准的更新
2016年11月1日
最后验证
2016年11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.