An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice
2018年5月10日 更新者：Hoffmann-La Roche
A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE
This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.
研究概览
研究类型
观察性的
注册 (实际的)
140
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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Luxembourg、卢森堡、2540
- Höpital Kirchberg; Rheumatology
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Aalst、比利时、9300
- ASZ Aalst
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Assebroek、比利时、8310
- AZ Sint Lucas Brugge
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Brugge、比利时、8000
- AZ Sint Jan
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Bruxelles、比利时、1070
- Hospital Erasme; Neurologie
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Bruxelles、比利时、1050
- HIS (Etterbeek Ixelles)
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Bruxelles、比利时、1000
- CHU St Pierre (César de Paepe)
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Dendermonde、比利时、9200
- AZ Sint Blasius (Dendermonde)
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Edegem、比利时、2650
- UZ Antwerpen
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Genk、比利时、3600
- ReumaClinic
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Genk、比利时、3600
- Reumacentrum Genk
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Gilly (Charleroi)、比利时、6000
- GHdC Site Saint-Joseph
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Kortrijk、比利时、8500
- AZ Groeninge
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Liège、比利时、4000
- CHU Sart-Tilman
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Lokeren、比利时、9160
- Private practice
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Mont-godinne、比利时、5530
- CHU UCL Mont-Godinne
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Oostende、比利时、8400
- AZ Damiaan
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Oudenaarde、比利时、9700
- AZ Oudenaarde
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Sijsele、比利时、8340
- AZ Alma vzw (Sijsele)
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Westmalle、比利时、2390
- AZ Sint Jozef Malle
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Wilrijk、比利时、2610
- Sint Augustinus Wilrijk
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Zoersel、比利时、2980
- CVBA Diagnosecentrum Voorkempen
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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
Participant with a diagnosis of moderate to severe RA defined as DAS28 more than or equal to (>=) 3.7, naïve to TCZ and in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria
描述
Inclusion Criteria:
- Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
- Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria
Exclusion Criteria:
- Participants who have received TCZ >8 weeks prior to the enrolment visit
- Participants who have previously received TCZ SC
- Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC
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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Rheumatoid Arthritis participants treated with Tocilizumab SC
Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
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Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
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 |
大体时间 |
|---|---|
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Correlation coefficient between DAS28 - erythrocyte sedimentation rate (DAS28-ESR) and Clinical Disease Activity Index (CDAl)
大体时间：Up to Week 24
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Up to Week 24
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Correlation Coefficient Between CDAI and simplified disease activity index (SDAI) and Between SDAI and DAS28-ESR
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants to achieve low disease activity (LDA) using DAS28 (less than or equal to [<=] 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
大体时间：Up to Week 24
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Up to Week 24
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Time to achieve low disease activity (LDA) using DAS28 (<= 3.2), CDAl (<=10.0) and SDAI (<=11 .0)
大体时间：Up to week 24
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Up to week 24
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Percentage of participants to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
大体时间：Up to Week 24
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Up to Week 24
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Time to achieve disease remission using DAS28-ESR (<2.6), CDAl (<=2.8) and SDAI (<=3.3)
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
大体时间：Up to Week 24
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Up to Week 24
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Time to achieve a clinically meaningful improvement in DAS28-ESR (reduction of at least 1.2 units)
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants to achieve a major and minor improvement in CDAl (more than or equal to [>=]13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)
大体时间：Up to Week 24
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Up to Week 24
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Time to achieve a major and minor improvement in CDAl (>=13.9 and >=6.7, respectively) and SDAI (>=17.1 and >=6.9, respectively)
大体时间：Up to Week 24
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Up to Week 24
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Change from baseline in total tender joint count (TJC)
大体时间：Up to Week 24
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Up to Week 24
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Change from baseline in total swollen joint count (SJC)
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants having TJC <=1
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants having SJC <=1
大体时间：Up to Week 24
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Up to Week 24
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Patient Global Assessment of disease activity visual analogue scale (VAS) score
大体时间：Up to Week 24
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Up to Week 24
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Physician Global Assessment of disease activity VAS score
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants having CRP <=1mg/dl
大体时间：Up to Week 24
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Up to Week 24
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Health Assessment Questionnaire Disability Index (HAQ-DI)
大体时间：Up to Week 24
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Up to Week 24
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EQ-5D-5L Health Questionnaire (EuroQoL)
大体时间：Up to Week 24
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Up to Week 24
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Morisky Medication-Taking Adherence Scale (MMAS)
大体时间：Up to Week 24
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Up to Week 24
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Percentage of participants using TCZ in monotherapy
大体时间：At baseline
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At baseline
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Percentage of participants using TCZ in combination with disease-modifying antirheumatic drug's (DMARD's)
大体时间：At baseline
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At baseline
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Percentage of participants presenting a high inflammation (DAS28-ESR >5.1)
大体时间：At baseline
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At baseline
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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。
合作者
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)
2015年10月31日
初级完成 (实际的)
2017年10月23日
研究完成 (实际的)
2017年10月23日
研究注册日期
首次提交
2015年9月16日
首先提交符合 QC 标准的
2015年9月16日
首次发布 (估计)
2015年9月17日
研究记录更新
最后更新发布 (实际的)
2018年5月11日
上次提交的符合 QC 标准的更新
2018年5月10日
最后验证
2018年5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.