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Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

2016年6月10日 更新者：Hoffmann-La Roche

A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACT-UP)

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.

研究概览

地位

完全的

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

37

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

  • 澳大利亚
    • New South Wales
      • Campsie、New South Wales、澳大利亚、2194
      • Coffs Harbour、New South Wales、澳大利亚、2450
      • New Lambton、New South Wales、澳大利亚、2305
    • South Australia
      • Woodville、South Australia、澳大利亚、5011
    • Victoria
      • Heidelberg、Victoria、澳大利亚、3084
      • Morwell、Victoria、澳大利亚、3842
    • Western Australia
      • Shenton Park、Western Australia、澳大利亚、6008

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

RA participants treated with tocilizumab

描述

Inclusion Criteria:

  • Severe RA.
  • Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
  • Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.

Exclusion Criteria:

  • Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
  • Previous tocilizumab treatment in a clinical trial or for compassionate use.
  • Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
  • History of autoimmune disease or any joint inflammatory disease other than RA.

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
Rheumatoid Arthritis (RA) Participants (All Groups)
Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.
其他：观察性研究

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
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
大体时间：Month 6
Percentage of participants on tocilizumab treatment at Month 6 was calculated as: [(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)] multiplied by 100.
Month 6
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
大体时间：Baseline
Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
Baseline
Patient Global Assessment of Disease Activity Using VAS at Baseline
大体时间：Baseline
The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.
Baseline
Physician Global Assessment of Disease Activity Using VAS at Baseline
大体时间：Baseline
Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.
Baseline
Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
大体时间：Baseline
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Baseline
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
大体时间：Baseline
TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Baseline
Erythrocyte Sedimentation Rate (ESR) at Baseline
大体时间：Baseline
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.
Baseline
C-Reactive Protein (CRP) at Baseline
大体时间：Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
大体时间：Baseline
Baseline
Median Dose at Month 6
大体时间：Month 6
Month 6
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
大体时间：Baseline up to Month 6
Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.
Baseline up to Month 6
Mean Dosing Interval at Month 6
大体时间：Month 6
The time interval between two successive doses in days was reported.
Month 6
Percentage of Participants With Reasons Who Discontinued Tocilizumab
大体时间：Baseline up to Month 6
Baseline up to Month 6
Time to Restoration of Initial Dosing Regimen
大体时间：Baseline up to Month 6
Baseline up to Month 6
Percentage of Participants by Reason for Choice of Monotherapy at Baseline
大体时间：Baseline up to Month 6
Baseline up to Month 6
Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
大体时间：Baseline, Month 6
Baseline, Month 6
Duration of Tocilizumab Treatment
大体时间：Baseline up to Month 6
Baseline up to Month 6
Percentage of Participants by Duration of Morning Stiffness
大体时间：Baseline, Month 3, Month 6
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (<) 30 minutes, between 30 and 240 minutes, greater than (>) 240 minutes and whole day.
Baseline, Month 3, Month 6
Percentage of Participants With and Without Morning Stiffness
大体时间：Baseline, Month 3, Month 6

Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria:

  1. Presence of participant's joints stiff when woke up that day, measured as yes or no
  2. Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: < 30 minutes, between 30 and 240 minutes, > 240 minutes, and the whole day.
  3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.
Baseline, Month 3, Month 6
Percentage of Participants Adhering to Local Label for Adverse Events
大体时间：Baseline up to Month 6
Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.
Baseline up to Month 6
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
大体时间：Baseline, Month 3, Month 6
The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.
Baseline, Month 3, Month 6
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
大体时间：Month 3 and Month 6
Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.
Month 3 and Month 6
Clinical Disease Activity Index (CDAI) Score by Visit
大体时间：Baseline, Month 3, Month 6
The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.
Baseline, Month 3, Month 6
Change From Baseline in TJC and SJC at Month 3 and Month 6
大体时间：Baseline, Month 3, Month 6
TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Baseline, Month 3, Month 6
Simplified Disease Activity Index (SDAI) Score by Visit
大体时间：Baseline, Month 3, Month 6
The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.
Baseline, Month 3, Month 6
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment
大体时间：Month 3 and Month 6
ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.
Month 3 and Month 6
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.
Baseline, Month 3, Month 6
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.
Baseline, Month 3, Month 6
Change From Baseline in HAQ-DI Score at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.
Baseline, Month 3, Month 6
Change From Baseline in VAS-Fatigue at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.
Baseline, Month 3, Month 6
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
Baseline, Month 3, Month 6
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
大体时间：Baseline, Month 3, Month 6
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.
Baseline, Month 3, Month 6

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

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7月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2012年9月5日

首先提交符合 QC 标准的

2012年9月7日

首次发布 (估计)

2012年9月12日

研究记录更新

最后更新发布 (估计)

2016年7月21日

上次提交的符合 QC 标准的更新

2016年6月10日

最后验证

2016年6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

  • ML28144

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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