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临床前类风湿关节炎疾病演进的前瞻性多维度精准防控研究
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注册号:

Registration number:

ChiCTR1900022605 

最近更新日期:

Date of Last Refreshed on:

2019-04-18 

注册时间:

Date of Registration:

2019-04-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

临床前类风湿关节炎疾病演进的前瞻性多维度精准防控研究 

Public title:

Prospective Multidimensional Precision Prevention and Control Study for the Evolution of Preclinical Rheumatoid Arthritis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

临床前类风湿关节炎疾病演进的前瞻性多维度精准防控研究 

Scientific title:

Prospective Multidimensional Precision Prevention and Control Study for the Evolution of Preclinical Rheumatoid Arthritis 

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:

王佳 

研究负责人:

刘毅 

Applicant:

Wang Jia 

Study leader:

Liu Yi 

申请注册联系人电话:

Applicant telephone:

+86 17612184867 

研究负责人电话:

Study leader's telephone:

+86 13880927123 

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:

wangayimu@163.com 

研究负责人电子邮件:

Study leader's E-mail:

hxprera@163.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:

上海长宁区宣化路300号华宁国际中区1206室 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号华西医院风湿免疫科 

Applicant address:

Room 1206, Huaning International Central District, 300 Xuanhua Road, Changning District, Shanghai, China 

Study leader's address:

37 Guoxue Lane, Chengdu, Sichuan, 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:

宁波立华制药有限公司 

Applicant's institution:

Ningbo Lihua Pharmaceutical Co. LTD 

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:

2017年审151号 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川大学华西医院生物医学伦理分委会 

Name of the ethic committee:

Biomedical Ethics Sub-Committee of Huaxi Hospital, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-10-18 

伦理委员会联系人:

史小媛 

Contact Name of the ethic committee:

Shi Xiaoyuan 

伦理委员会联系地址:

四川省成都市国学巷37号第五住院大楼 

Contact Address of the ethic committee:

Room 412, Old 8th Teaching Building, West China Hospital, Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 028 85422654 

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:

四川大学华西医院风湿免疫科 

Primary sponsor:

Department of Rheumatology, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市国学巷37号第五住院大楼五楼 

Primary sponsor's address:

5th Floor, 5th Inpatient Building, 37 Guoxue Lane, Chengdu, Sichuan, 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):

四川省

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

华西医院

具体地址:

四川省成都市国学巷37号

Institution
hospital:

West China Hospital, Sichuan University

Address:

37 Guoxue Lane, Chengdu, Sichuan, China

经费或物资来源:

宁波立华制药有限公司 

Source(s) of funding:

Ningbo Lihua Pharmaceutical Co. LTD 

研究疾病:

类风湿关节炎 

Target disease:

Rheumatoid arthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

将健康体检人群ACPAs阳性者分成2组,一组予以帕夫林口服,一组随访观察,留取血清标本检测相应生化指标抗体,留取粪便进行 16S测序研究肠道菌群,通过对照研究,以明确ACPAs阳性者肠道菌群的特点,及 ACPAs 阳性者在疾病演进过程中肠道菌群的变化及关系,帕夫林干预的临床疗效和对肠道菌群的影响及机制。以实现对RA的早期干预、防控、阻止RA的发生发展,延缓其演进进程,最终实现个性化医疗、精准防控的目的。  

Objectives of Study:

The ACPS-positive healthy subjects are divided into two groups. One group is given TGP orally and the other is followed up, collecting serum samples for detecting corresponding biochemical index antibodies and feces for sequencing to study intestinal flora. Objective: By a controlled study to identify characteristics of intestinal flora of ACPA-positive people, changes and relationships of intestinal flora as the disease progresses, and the clinical effect of TGP intervention and its influence to intestinal flora and mechanism, so as to achieve early intervention, prevention and control of rheumatoid arthritis occurrence and development, slow down the disease evolution process and finally achieve the purpose of personalized medicine and precise prevention and control of disease. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1.年龄≥18岁至≤75岁(至筛选之日);2.ACPAs 阳性;3.无关节晨僵、肿痛等关节炎表现;4.无风湿性疾病既往史,如类风湿关节炎、系统性红斑狼疮等;5.未用过改善病情抗风湿药物(DMARDs,包括生物制剂);6.未用过糖皮质激素;7.入选前3个月内未参加任何药物试验者;8.了解观察研究全过程,自愿参加并签署知情同意书。  

Inclusion criteria

1. Aged 18 to 75 years; 2. ACPAs-positive; 3. Understanding the whole process of observation and study, volunteering to participate in the clinical trial and having signed the informed consent. 

排除标准:

1.孕妇、准备妊娠或哺乳期妇女;2.近1年内有慢性腹泻或消化性溃疡病史者;3.有精神疾患,酗酒史,药物或其他物品滥用者;4.已明确诊断其他风湿性疾病者(包括痛风,骨关节炎);5.恶性肿瘤患者;6.对试验药物过敏者;7.具有其他各种研究者认为不能加入此临床试验的情况。  

Exclusion criteria:

1. Pregnant women, women trying to conceive or lactating women; 2. People with history of chronic diarrhea or peptic ulcer disease during the last year; 3. People with history of mental disease, alcoholism, drug or other substance abuse; 4. People with diagnosis of other rheumatic diseases(including gout, osteoarthritis); 5. People with malignant tumors; 6. People with allergy to the experimental drugs; 7. Any condition in which the researchers consider that people can not be included in the trial. 

研究实施时间:

Study execute time:

From2016-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

白芍总苷组

样本量:

200

Group:

TGP group

Sample size:

干预措施:

服用白芍总苷600mg Bid

干预措施代码:

Intervention:

Taking total glucosides of white peony 600mg Bid

Intervention code:

组别:

对照组

样本量:

200

Group:

Control group

Sample size:

干预措施:

none

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital, Sichuan 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):

长海医院 

单位级别:

三甲医院 

Institution
hospital:

Changhai hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

枣庄 

Country:

China 

Province:

Shandong 

City:

Zaozhuang 

单位(医院):

枣庄市立医院 

单位级别:

三甲医院 

Institution
hospital:

Zaozhuang Municipal 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):

上海光华中西医结合医院 

单位级别:

三甲医院 

Institution
hospital:

Shanghai Guanghua Integrated traditional Chinese and Western Medicine Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

抗环瓜氨酸多肽抗体

指标类型:

主要指标 

Outcome:

anti CCP antibody

Type:

Primary indicator 

测量时间点:

筛选访视和年度随访

测量方法:

电化学发光法

Measure time point of outcome:

Screening visits and annual follow-up visits

Measure method:

electrochemiluminescence

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

粪便

组织:

Sample Name:

stool

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 75 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):

非随机,由受试者自愿选择药物干预组或观察随访组

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

Non-randomly, the subjects voluntarily chose the drug intervention group or the observation and follow-up group.

盲法:

N/A

Blinding:

N/A

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:

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):

临床试验公共管理平台ResMan(www.medresman.org)

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

ResMan (www.medresman.org)

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:

Electronic Data Capture, EDC

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-18
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