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An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

2016年1月12日 更新者：Hoffmann-La Roche

A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

1225

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

  • 乌克兰
      • Donetsk、乌克兰、83045
      • Kharkiv、乌克兰、61052
      • Kmelnytskyy、乌克兰、29000
      • Kyiv、乌克兰、02125
      • Kyiv、乌克兰、03151
      • Kyiv、乌克兰、1023
      • Odesa、乌克兰、65026
      • Uzhgorod、乌克兰、88000
      • Zaporizhzhya、乌克兰、69600
  • 乌拉圭
      • Montevideo、乌拉圭、11000
      • Montevideo、乌拉圭、11800
  • 危地马拉
      • Ciudad de Guatemala、危地马拉
  • 厄瓜多尔
      • Cuenca、厄瓜多尔
      • Esmeraldas、厄瓜多尔、EC080150
      • Guayaquil、厄瓜多尔、EC090114
      • Portoviejo、厄瓜多尔
      • Quito、厄瓜多尔、005932
      • Quito、厄瓜多尔、EC170135
      • Quito、厄瓜多尔、EC170412
  • 哥伦比亚
      • Barranquilla、哥伦比亚
      • Bogota、哥伦比亚
      • Bucaramanga、哥伦比亚
      • Medellin、哥伦比亚
  • 墨西哥
      • Guadalajara、墨西哥、44650
      • Guadalajara、墨西哥、44600
      • Guadalajara、墨西哥、45040
      • Mexicali、墨西哥、21100
      • Mexico Ctiy、墨西哥、07760
  • 巴拿马
      • Panama City、巴拿马、32400
  • 希腊
      • Athens、希腊、11527
      • Athens、希腊、155 62
      • Patra、希腊、26335
      • Thessaloniki、希腊、56429
      • Thessaloniki、希腊、544 65
  • 德国
      • Aachen、德国、52064
      • Bad Aibling、德国、83043
      • Bad Neuenahr-Ahrweiler、德国、53474
      • Bayreuth、德国、95445
      • Berlin、德国、13055
      • Dresden、德国、01109
      • Erfurt、德国、99096
      • Erlangen、德国、91056
      • Fulda、德国、36043
      • Hamburg、德国、22767
      • Hamburg、德国、22147
      • Heidelberg、德国、69121
      • Herne、德国、44652
      • Köln、德国、50937
      • Ludwigsfelde、德国、14974
      • München、德国、81541
      • München、德国、80639
      • Passau、德国、94032
      • Rostock、德国、18059
      • Stuttgart、德国、70178
      • Traunstein、德国、83278
      • Wuppertal、德国、42105
  • 意大利
    • Abruzzo
      • Coppito、Abruzzo、意大利、67100
      • Pescara、Abruzzo、意大利、65100
    • Calabria
      • Reggio Calabria、Calabria、意大利、89133
    • Campania
      • Avellino、Campania、意大利、83100
      • Napoli、Campania、意大利、80131
      • Napoli、Campania、意大利、80144
      • Salerno、Campania、意大利、84131
    • Friuli-Venezia Giulia
      • Udine、Friuli-Venezia Giulia、意大利、33100
    • Lazio
      • Roma、Lazio、意大利、00133
      • Roma、Lazio、意大利、00189
    • Liguria
      • Arenzano、Liguria、意大利、16011
    • Lombardia
      • Brescia、Lombardia、意大利、25123
      • Legnano、Lombardia、意大利、20025
      • Milano、Lombardia、意大利、20157
      • Milano、Lombardia、意大利、20162
    • Marche
      • Jesi Ancona、Marche、意大利、60035
    • Molise
      • Agnone、Molise、意大利、86081
    • Piemonte
      • Torino、Piemonte、意大利、10126
      • Torino、Piemonte、意大利、10128
    • Puglia
      • Brindisi、Puglia、意大利、72100
      • Martina Franca、Puglia、意大利、74015
      • San Cesario Di Lecce、Puglia、意大利、73016
    • Sicilia
      • Catania、Sicilia、意大利、95124
    • Toscana
      • Prato、Toscana、意大利、59100
    • Umbria
      • Perugia、Umbria、意大利、06122
  • 比利时
      • AYE、比利时、6900
      • Aalst、比利时、9300
      • Assebroek、比利时、8310
      • Bruxelles、比利时、1050
      • Bruxelles、比利时、1000
      • Edegem、比利时、2650
      • Genk、比利时、3600
      • Gent、比利时、9000
      • Godinne、比利时、5530
      • Heusy、比利时、4802
      • Liège、比利时、4000
      • Oostende、比利时、8400
      • Verviers、比利时、4800
      • Westmalle、比利时、2390
  • 瑞士
      • Aarau、瑞士、5000
      • Basel、瑞士、4031
      • Chur、瑞士、7000
      • St. Gallen、瑞士、9007
  • 英国
      • Barnsley、英国、S75 2EP
      • Basildon、英国、SS16 5NL
      • Basingstoke、英国、RG24 9NA
      • Brighton、英国、BN2 5BE
      • Cannock、英国、WS11 5XY
      • Cardiff、英国、CF14 4XW
      • Chertsey、英国、KT16 0PZ
      • Crawley、英国、RH11 7DH
      • Darlington、英国、DL3 6HX
      • Enfield、英国、EN2 8JL
      • Grimsby、英国、DN33 2BA
      • Guildford、英国、GU2 7XX
      • Ipswich、英国、IP4 5PD
      • Kettering、英国、NN16 8UZ
      • Lancaster、英国、LA1 4RP
      • Leeds、英国、LS7 4SA
      • Llandudno、英国、LL30 1LB
      • London、英国、W6 8RF
      • London、英国、SW17 0QT
      • London、英国、SE18 4QH
      • Luton、英国、LU4 0DZ
      • Maidstone、英国、ME16 9QQ
      • Margate、英国、CT9 4AN
      • North Shields、英国、NE29 8NH
      • Oswestry、英国、SY10 7AG
      • Plymouth、英国、PL6 8DH
      • Portsmouth、英国、PO6 3LY
      • Reading、英国、RG1 5AN
      • Rhyl、英国、LL18 5UJ
      • Romford、英国、RM7 0AG
      • Sheffield、英国、S10 2JF
      • Stockport、英国、SK2 7JE
      • Sunderland、英国、SR4 7TP
      • Swindon、英国、SN3 6BB
      • Torquay、英国、TQ2 7AA
      • Warrington、英国、WA5 1QG
      • Wirral、英国、CH49 5PE
      • Wolverhampton、英国、WV10 0QP
      • Wrightington、英国、WN6 9EP
  • 葡萄牙
      • Almada、葡萄牙、2801-951
      • Amadora、葡萄牙、2720-276
      • Lisboa、葡萄牙、1649-035
      • Lisboa、葡萄牙、1069-166
      • Porto、葡萄牙、4200-319
      • Porto、葡萄牙、4099-001
      • Vila Nova de Gaia、葡萄牙、4400-129
  • 西班牙
      • Madrid、西班牙、28006
      • Madrid、西班牙、28905
      • Madrid、西班牙、28007
    • Madrid
      • Fuenlabrada、Madrid、西班牙、28942
      • San Sebastian de los Reyes、Madrid、西班牙、28702
  • 阿根廷
      • Catamarca Capital、阿根廷、4700
      • Mendoza、阿根廷、5500
      • Mendoza、阿根廷、5501
      • Rosario、阿根廷、S2000PBJ

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

概率样本

研究人群

Adult patients with rheumatoid arthritis

描述

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Diagnosis of rheumatoid arthritis
  • Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
  • Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

  • Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
  • Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
  • Patients whose first biologic is rituximab, abatacept or anakinra.
  • Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

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
队列

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
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
大体时间：Baseline and Week 24
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the 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.
Baseline and Week 24

次要结果测量

结果测量
措施说明
大体时间
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
大体时间：Baseline and Week 52
Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Week 52
Mean Change From Baseline in Erythrocyte Sedimentation Rate
大体时间：Baseline, Week 24, Week 52
Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.
Baseline, Week 24, Week 52
Mean Change From Baseline in C-reactive Protein
大体时间：Baseline, Week 24, Week 52
Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.
Baseline, Week 24, Week 52
Mean Change From Baseline in Swollen Joint Count
大体时间：Baseline, Week 24, Week 52
A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Tender Joint Count
大体时间：Baseline, Week 24, Week 52
A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.
Baseline, Week 24, Week 52
Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
大体时间：Baseline, Week 24, Week 52
Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.
Baseline, Week 24, Week 52
Mean Change From Baseline in Physician Global Assessment Score
大体时间：Baseline, Week 24, Week 52
The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Loss of Efficacy or Development of Intolerance to Biologic Therapy
大体时间：Up to Week 52
Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.
Up to Week 52
Proportion of Participants Who Terminated Biologic Treatment
大体时间：Up to Week 52
The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.
Up to Week 52
Reasons for Treatment Discontinuation
大体时间：Up to Week 52
The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.
Up to Week 52
Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
大体时间：Up to end of treatment
The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.
Up to end of treatment
Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
大体时间：Up to Week 52
An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.
Up to Week 52
Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
大体时间：Up to Week 52
An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Up to Week 52
Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
大体时间：Up to Week 52
Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.
Up to Week 52
Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
大体时间：Baseline, Week 24, Week 52
The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.
Baseline, Week 24, Week 52
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
大体时间：Baseline, Week 24, Week 52
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Baseline, Week 24, Week 52
Mean Change From Baseline in Visual Analogue Scale Pain Score
大体时间：Baseline, Week 24, Week 52
VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Baseline, Week 24, Week 52
Shift From Baseline in Morning Stiffness
大体时间：Baseline, Week 24, Week 52
Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL
Baseline, Week 24, Week 52
Change From Baseline in Patient Global Assessment of Disease Activity
大体时间：Baseline, Week 24, Week 52
The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.
Baseline, Week 24, Week 52

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。

赞助

Hoffmann-La Roche

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。

一般刊物

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2月1日

初级完成 (实际的)

2015年2月1日

研究完成 (实际的)

2015年2月1日

研究注册日期

首次提交

2012年2月28日

首先提交符合 QC 标准的

2012年2月28日

首次发布 (估计)

2012年3月5日

研究记录更新

最后更新发布 (估计)

2016年2月10日

上次提交的符合 QC 标准的更新

2016年1月12日

最后验证

2016年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MA27950

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.

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