今天是:2019-12-12 星期四

小剂量激素联合甲氨蝶呤和羟氯喹治疗早期类风湿性关节炎的疗效及安全性
下载XML文档

注册号:

Registration number:

ChiCTR1900026116 

最近更新日期:

Date of Last Refreshed on:

2019-09-22 

注册时间:

Date of Registration:

2019-09-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

小剂量激素联合甲氨蝶呤和羟氯喹治疗早期类风湿性关节炎的疗效及安全性 

Public title:

The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

小剂量激素联合甲氨蝶呤和羟氯喹治疗早期类风湿性关节炎的疗效及安全性 

Scientific title:

The efficacy and safety of low-dose glucocorticoids combined withmethotrexate and hydroxychloroquine in the treatment of early rheumatoid arthritis: a randomized, double-blinded, controlled trial 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

华丽 

研究负责人:

华丽 

Applicant:

Hua Li 

Study leader:

Hua Li 

申请注册联系人电话:

Applicant telephone:

+86 13758992315 

研究负责人电话:

Study leader's telephone:

+86 13758992315 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

49124571@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

49124571@qq.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

浙江省金华市人民东路365号 

研究负责人通讯地址:

浙江省金华市人民东路365号 

Applicant address:

365 East Renmin Road, Jinhua, Zhejiang, China 

Study leader's address:

365 East Renmin Road, Jinhua, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江省金华市中心医院 

Applicant's institution:

Central Hospital of Jinhua, Zhejiang 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

(2014)伦审第(8)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

金华市中心医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Jinhua Central Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

吴渝骐鸣 

Contact Name of the ethic committee:

Wu Yu-Qi-Min 

伦理委员会联系地址:

金华市人民东路365号9号楼J06室 

Contact Address of the ethic committee:

Room J06, Building 9, 365 East Renmin Road, Jinhua, Zhejiang, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

浙江省金华市中心医院 

Primary sponsor:

Central Hospital of Jinhua 

研究实施负责(组长)单位地址:

金华市人民东路365号 

Primary sponsor's address:

365 East Renmin Road, Jinhua, Zhejiang, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

金华

Country:

China

Province:

Zhejiang

City:

Jinhua

单位(医院):

金华市中心医院

具体地址:

金华市人民东路365号

Institution
hospital:

Central Hospital of Jinhua

Address:

365 East Renmin Road, Jinhua, Zhejiang, China

经费或物资来源:

金华市科技局 

Source(s) of funding:

Jinhua Municipal Science and Technology Bureau 

研究疾病:

类风湿性关节炎 

Target disease:

rheumatoid arthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

上市后药物 

Study phase:

研究目的:

阐明小剂量激素联合MTX、HCQ在ERA患者中的疗效(临床、实验室、放射学尤其是磁共振成像(Magnetic resonance imaging,MRI)上的改变。论证上述方案的安全性。进一步探讨小剂量激素的疗程、减量方案。 

Objectives of Study:

To clarify the effect of small dose hormones combined with MTX and HCQ in ERA patients (clinical, laboratory, radiology, especially Magnetic resonance imaging (MRI) changes. Demonstrate the safety of the above scheme. Further discussion on the treatment of small dose hormones and the reduction program. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

以100名未接受过任何药物治疗,且病程小于12个月,符合2009年美国风湿病学会(ACR)和欧洲抗风湿病联盟(EULAR)提出的新RA分类标准的ERA患者为研究对象。 

Inclusion criteria

100 untreated patients, the course less than 12 months, in line with the 2009 American rheumatism association (ACR) and the European Union for resistance rheumatism (EULAR) proposed new RA classification standard ERA patients as the research object. 

排除标准:

患禁止激素治疗疾病(例如糖尿病、易致脆性故骨折的骨质疏松)的患者;前2个月有过较严重的感染(如肝炎、肺炎和肾盂肾炎等)者;孕妇、哺乳期妇女;结核病患者;患有肿瘤、多发性硬化、中枢性神经脱髓鞘病变和充血性心力衰竭等疾病者;有其它严重心、肝、肾等重要脏器和血液、内分泌系统病变及病史者。 

Exclusion criteria:

Patients who are prohibited from treating diseases such as diabetes and brittle bones with brittle fractures;In the first 2 months, there were serious infections (such as hepatitis, pneumonia and pyelonephritis); Pregnant women and lactating women; TB patients; Patients with tumors, multiple sclerosis, central nervous demyelination and congestive heart failure; Have other serious heart, liver, kidney and other important viscera and blood, endocrine system pathological changes and medical history. 

研究实施时间:

Study execute time:

From2014-06-01To 2017-06-01 

干预措施:

Interventions:

组别:

试验组

样本量:

40

Group:

Experimental group

Sample size:

干预措施:

强的松片加甲氨蝶呤片加硫酸羟氯喹

干预措施代码:

Intervention:

Prednisone+methotrexate+Hydrochloroquine

Intervention code:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

安慰剂加甲氨蝶呤片加硫酸羟氯喹

干预措施代码:

Intervention:

placebo+methotrexate+Hydrochloroquine

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江省 

市(区县):

金华市 

Country:

China 

Province:

Zhejiang 

City:

Jinhua 

单位(医院):

金华市中心医院 

单位级别:

三甲 

Institution
hospital:

Central Hospital of Jinhua  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

DAS28

指标类型:

主要指标 

Outcome:

DAS28

Type:

Primary indicator 

测量时间点:

0、1、3、6、12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

关节磁共振

指标类型:

主要指标 

Outcome:

joint MRI

Type:

Primary indicator 

测量时间点:

0、12月

测量方法:

MRI

Measure time point of outcome:

0, 12month

Measure method:

MRI

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 21 years
最大 Max age 73 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

事先由随机数字表产生80个随机数字,由不参加病例入组和随访的课题组成员将符合纳入及排除标准的80例患者连续按1:1随机分入试验组和对照组

Randomization Procedure (please state who generates the random number sequence and by what method):

80 random numbers were generated from the random number table in advance. The 80 members of the study group who did not participate in the group and follow-up were randomly divided into the test group and the control group according to 1:1.

盲法:

未说明

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

论文公开发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

article published

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

由病例收集者将入组患者资料收集后按随访时间定期录入电脑。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Patients' data collected by doctors and follow-up were promptly entered into the computer and updated regularly according to follow-up time.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-09-22
返回列表