此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

2013年4月3日更新者：Chugai Pharma Taiwan

24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.

研究概览

地位

完全的

条件

类风湿关节炎

干预/治疗

药品：Tocilizumab+Methotrexate(MTX)

研究类型

介入性

注册 (实际的)

阶段

第三阶段

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

台湾
- - Chiayi、台湾
    - Buddhist Dalin Tzu Chi General Hospital
  - Kaohsiung、台湾
    - Kaohsiung Medical University Hospital
  - Kaohsiung、台湾
    - Kaohsiung Veterans General Hospital
  - Kaohsiung、台湾
    - Chang Gung Memorial Hospital -Kaohsiung
  - Taichung、台湾
    - Taichung Veterans General Hospital
  - Taichung、台湾
    - Chung Shan Medical University Hospital
  - Tainan、台湾
    - National Cheng Kung University Hospital
  - Taipei、台湾
    - Tri-Service General Hospital
  - Taipei、台湾
    - National Taiwan University Hospital
  - Taipei、台湾
    - Taipei Veterans General Hospital
  - Taipei、台湾
    - Cathay General Hospital
  - Taoyuan、台湾
    - Chang Gung Memorial Hospital - Linkou

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

20年至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW).
Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20

Exclusion Criteria:

Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.

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

主要用途：治疗
分配：非随机化
介入模型：单组作业
屏蔽：无（打开标签）

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Proportion of patients with an American College of Rheumatology 70 (ACR70) response 大体时间：at week 24	at week 24

次要结果测量

结果测量	大体时间
Proportion of patients with ACR50 response 大体时间：at week 24	at week 24
Proportion of patients with ACR20 response 大体时间：at week 24	at week 24
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively 大体时间：at baseline and week 24	at baseline and week 24
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28) 大体时间：at baseline and week 24	at baseline and week 24
Proportion of patients achieving DAS28 remission (DAS28 < 2.6) 大体时间：at week 24	at week 24
Adverse event incidence 大体时间：from baseline to week 24	from baseline to week 24
Mean change from baseline to evaluation visits in vital signs 大体时间：from baseline to week 24	from baseline to week 24
Change in Electrocardiogram. From baseline to evaluation visits 大体时间：from baseline to week 24	from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative hematological exam results. 大体时间：from baseline to week 24	from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results. 大体时间：from baseline to week 24	from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results. 大体时间：from baseline to week 24	from baseline to week 24
Mean change from baseline visit to evaluation visits in quantitative urinalysis results. 大体时间：from baseline to week 24	from baseline to week 24

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

Chugai Pharma Taiwan

调查人员

学习椅：Yoshiaki Someya、Chugai Pharma Taiwan

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

2011年5月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年4月1日

研究注册日期

首次提交

2011年5月3日

首先提交符合 QC 标准的

2011年5月4日

首次发布 (估计)

2011年5月5日

研究记录更新

最后更新发布 (估计)

2013年4月4日

上次提交的符合 QC 标准的更新

2013年4月3日

最后验证