A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
2016年10月7日 更新者：Hoffmann-La Roche
Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD
This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs.
Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.
研究概览
研究类型
观察性的
注册 (实际的)
50
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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Podgorica、黑山、81000
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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
Participants with RA and an inadequate response to non-biologic DMARDs.
描述
Inclusion Criteria:
- Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
- Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
- Initiating treatment with tocilizumab according to SPC
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Prior history or current inflammatory joint disease other than RA
- Previous treatment with any biological drug used in the treatment of RA
- Previous treatment with tocilizumab
- Any contraindication to treatment with tocilizumab
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Pregnant women or nursing (breastfeeding) mothers
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：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
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Tocilizumab in Moderate to Severe Active RA
Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed.
The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment.
The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
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Participants will receive tocilizumab treatment according to effective official SPC.
The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
其他名称：
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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 Participants With Adverse Events (AEs) and Serious AEs (SAEs)
大体时间：Baseline up to Week 24
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
AEs include both SAEs as well as non-serious AEs.
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Baseline up to Week 24
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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 Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
大体时间：Baseline, Week 24
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EULAR response was based on 28-joint disease activity score (DAS28).
The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline (CFB) in DAS28 score and the level of disease activity reached (absolute DAS28 score).
Good responders had a CFB greater than (>) 1.2 with a DAS28 score less than or equal to (<=) 3.2; moderate responders had a CFB >1.2 with a DAS28 score >3.2 to <= 5.1 or a change from baseline >0.6 to <= 1.2 with a DAS28 score <= 5.1; non-responders had a CFB <=0.6 or CFB >0.6 to <=1.2 with DAS28 >5.1.
Number of participants who achieved EULAR good response and EULAR moderate response were reported.
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Baseline, Week 24
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Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
大体时间：Baseline up to Week 24
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Baseline up to Week 24
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Time to Discontinuation Due to Lack of Efficacy
大体时间：Baseline up to Week 24
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Baseline up to Week 24
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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5月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年9月1日
研究注册日期
首次提交
2012年6月8日
首先提交符合 QC 标准的
2012年6月11日
首次发布 (估计)
2012年6月12日
研究记录更新
最后更新发布 (估计)
2016年12月1日
上次提交的符合 QC 标准的更新
2016年10月7日
最后验证
2016年10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.
Tocilizumab的临床试验
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University Hospital for Infectious Diseases, Croatia未知
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Hoffmann-La Roche完全的
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Hoffmann-La Roche完全的类风湿关节炎法国, 德国, 意大利, 西班牙, 英国, 香港, 美国, 哥伦比亚, 巴西, 加拿大, 新西兰, 南非, 菲律宾, 俄罗斯联邦, 泰国, 新加坡, 保加利亚, 墨西哥, 澳大利亚, 立陶宛, 波兰, 阿根廷, 罗马尼亚, 波多黎各, 危地马拉, 秘鲁
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Azienda Unità Sanitaria Locale Reggio Emilia主动，不招人
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Hoffmann-La Roche完全的类风湿关节炎美国, 巴西, 英国, 加拿大, 阿根廷, 墨西哥, 奥地利, 以色列, 哥伦比亚, 秘鲁, 俄罗斯联邦, 菲律宾, 波多黎各, 德国, 希腊, 波兰, 西班牙, 法国, 新加坡, 中国, 南非, 匈牙利, 丹麦, 芬兰, 瑞典, 香港, 澳大利亚, 危地马拉, 爱尔兰, 意大利, 马其顿，前南斯拉夫共和国, 新西兰, 巴拿马, 葡萄牙, 泰国, 火鸡
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Azienda Ospedaliero, Universitaria Pisana; Istituto Auxologico Italiano; Azienda Ospedaliera "Sant... 和其他合作者招聘中
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Damanhour UniversityPrincipal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University; Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University 和其他合作者招聘中