今天是:2019-12-10 星期二

吗替麦考酚酯(MMF)对减少伴有高抗dsDNA抗体滴度的初发系统性红斑狼疮(SLE)患者远期靶器官损害的随机对照研究
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注册号:

Registration number:

ChiCTR1800017540 

最近更新日期:

Date of Last Refreshed on:

2018-08-03 

注册时间:

Date of Registration:

2018-08-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

吗替麦考酚酯(MMF)对减少伴有高抗dsDNA抗体滴度的初发系统性红斑狼疮(SLE)患者远期靶器官损害的随机对照研究 

Public title:

A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

吗替麦考酚酯(MMF)对减少伴有高抗dsDNA抗体滴度的初发系统性红斑狼疮(SLE)患者远期靶器官损害的随机对照研究 

Scientific title:

A randomized controlled trial for the long-term outcomes of MMF on new onset SLE patients with high titers of anti-dsDNA antibody for reducing main organ involvement 

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:

叶俊娜 

研究负责人:

叶俊娜 

Applicant:

Junna Ye 

Study leader:

Junna Ye 

申请注册联系人电话:

Applicant telephone:

+86 13817366731 

研究负责人电话:

Study leader's telephone:

+86 13817366731 

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:

yjn0912@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

yjn0912@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:

上海市瑞金二路197号老门诊5楼风湿免疫实验室 

研究负责人通讯地址:

上海市瑞金二路197号老门诊5楼风湿免疫实验室 

Applicant address:

197 Second Ruijin Road, Shanghai, China 

Study leader's address:

197 Second Ruijin Road, Shanghai, 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:

瑞金医院 

Applicant's institution:

Ruijin Hospital 

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:

[2018]120 

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:

瑞金医院涉及人体的科研项目伦理委员会 

Name of the ethic committee:

Ethics Committee of Ruijin Hospital's scientific research project  

伦理委员会批准日期:

Date of approved by ethic committee:

2013-07-22 

伦理委员会联系人:

王译峰 

Contact Name of the ethic committee:

YIfeng Wang 

伦理委员会联系地址:

上海市瑞金二路197号 

Contact Address of the ethic committee:

197 Second Ruijin Road, Shanghai, 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:

瑞金医院 

Primary sponsor:

Ruijin Hospital 

研究实施负责(组长)单位地址:

上海市瑞金二路197号 

Primary sponsor's address:

197 Second Ruijin Road, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

瑞金医院

具体地址:

上海市瑞金二路197号

Institution
hospital:

Ruijin Hospital

Address:

197 Second Ruijin Road, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

self-financing 

研究疾病:

系统性红斑狼疮 

Target disease:

systemic lupus erythematosus 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

系统性红斑狼疮是一种可以累及机体多器官的自身免疫性疾病。免疫系统的异常表现为体内存在大量的循环自身抗原(抗原产生增加和清除凋亡细胞能力下降),导致产生大量针对各种自身抗原的自身抗体并引起器官的免疫损伤。研究显示亚洲人群中的发病率约为8.4/10 万人/年,SLE可累及全身多个系统,如肾脏、心脏、肺脏,严重者可危及生命,给人们的生活和经济带来重大的经济负担。吗替麦考酚酯作为常用的免疫抑制剂,已经被广泛用于狼疮肾炎的诱导缓解和维持药物。在初发SLE患者中,很多患者伴有抗dsDNA抗体升高,抗dsDNA抗体又与狼疮肾炎的发病密切相关,并可导致多器官的累及。对于尚未出现系统累及的抗dsDNA抗体升高的初发SLE患者,MMF早期对之加以积极干预,是否改善这些患者的长期预后,值得研究。 

Objectives of Study:

Systemic lupus erythematosus is an autoimmune disease that can affect multiple organs in the body. The abnormality of the immune system is manifested by the presence of a large number of circulating autoantigens in the body (increased antigen production and decreased ability to clear apoptotic cells), resulting in the production of a lot of autoantibodies against various autoantigens and causing immune damage to organs. Studies have shown that the incidence rate in Asian population is about 8.4/100,000 people/year. SLE can affect multiple systems of the body, such as the kidney, heart, lung. serious people can be life-threatening, bringing significant economical burden to people's lives. As a commonly used immunosuppressive agent, mycophenolate mofetil(MMF) has been widely used for the induction of remission and maintenance of lupus nephritis. In patients with newly diagnosed SLE, many patients have elevated anti-double-stranded DNA antibodies, which are closely related to the onset of lupus nephritis and can cause multiple organ involvement. For patients with newly diagnosed SLE who have not experienced systemic involvement in elevated double-stranded DNA antibodies, it is worthwhile to study whether early intervention of MMF can improve the long-term prognosis of these patients. 

药物成份或治疗方案详述:

对照组:羟氯喹 200mg bid +0.5mg/kg/d激素 实验组:羟氯喹 200mg bid +0.5mg/kg/d激素+MMF 500mg bid 

Description for medicine or protocol of treatment in detail:

Control group: hydroxychloroquine 200mg bid +prednisone 0.5mg/kg/d Experimental group:hydroxychloroquine 200mg bid +prednisone 0.5mg/kg/d+Mycophenolate Mofetil 500mg bid 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

18-65岁,符合美国风湿学会1997版狼疮诊断标准,初发狼疮、抗dsDNA升高(ELISA法大于300)、未用激素及免疫抑制剂治疗的,无其他器官及系统累及。 

Inclusion criteria

Aged 18 to 65 years old and fulfill the American College of Rheumatology (ACR) SLE classification criteria 1997; New-onset SLE, with a anti-dsDNA antibody ELISA test value of more than 300. 

排除标准:

18岁以下;既往因其他自身免疫疾病长期使用激素或免疫抑制剂的;严重肝肾功能不全的;恶性肿瘤/处于感染期的病人;孕妇。 

Exclusion criteria:

SLE patient been treated with prednisone and immunosuppressive agents; With main organ involvement; with abnormal liver and kidney function; with cancer or infection; Pregnant. 

研究实施时间:

Study execute time:

From2018-08-01To 2021-08-01 

干预措施:

Interventions:

组别:

1

样本量:

50

Group:

1

Sample size:

干预措施:

激素

干预措施代码:

Intervention:

prednisone

Intervention code:

组别:

2

样本量:

50

Group:

2

Sample size:

干预措施:

吗替麦考酚酯

干预措施代码:

Intervention:

Mycophenolate Mofetil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

瑞金医院 

单位级别:

三甲 

Institution
hospital:

Ruijin Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

温州医科大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The first affiliated hospital wenzhou medical university  

Level of the institution:

Tertiary A Hospital 

国家:

国家 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

华山医院 

单位级别:

三甲 

Institution
hospital:

Huashan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

中山医院 

单位级别:

三甲 

Institution
hospital:

Zhongshan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

蚌埠医学院第一附属医院 

单位级别:

三甲 

Institution
hospital:

First Affiliated Hospital of Bengbu Medical College  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

浙江大学附属第一人民医院 

单位级别:

三甲 

Institution
hospital:

The first affiliated hospital,zhejiang University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

泰山医学院附属医院 

单位级别:

三甲 

Institution
hospital:

Affiliated hospital of Taishan medical university  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

抗dsDNA抗体

指标类型:

主要指标 

Outcome:

anti dsDNA antibody

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白

指标类型:

主要指标 

Outcome:

Ig

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补体

指标类型:

主要指标 

Outcome:

Complement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酐

指标类型:

次要指标 

Outcome:

creatinine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

次要指标 

Outcome:

glutamic-pyruvic transaminase

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞沉降率

指标类型:

主要指标 

Outcome:

ESR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标 

Outcome:

urinalysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

complete blood count

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 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):

叶俊娜,电脑随机

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

Junna Ye,computer randomiazation

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

01/01/2021,CRF

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

01/01/2021,CRF

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:

CRF and ResMan

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

CRF and ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-08-03
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