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英夫利昔单抗单用及联和硫唑嘌呤治疗克罗恩病的随访研究
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注册号:

Registration number:

ChiCTR1800020305 

最近更新日期:

Date of Last Refreshed on:

2018-12-23 

注册时间:

Date of Registration:

2018-12-23 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

英夫利昔单抗单用及联和硫唑嘌呤治疗克罗恩病的随访研究 

Public title:

A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

英夫利昔单抗单用及联合硫唑嘌呤治疗克罗恩病及抗英夫利昔单抗抗体关系 

Scientific title:

Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI 

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:

赵易尔 

研究负责人:

李爱民 

Applicant:

Yier Zhao 

Study leader:

Aimin Li 

申请注册联系人电话:

Applicant telephone:

+86 13246820732 

研究负责人电话:

Study leader's telephone:

+86 13580317630 

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:

zxs19670505@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lam0725@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:

广州市广州大道北1838号南方医科大学南方医院消化内科 

研究负责人通讯地址:

广州市广州大道北1838号南方医科大学南方医院消化内科 

Applicant address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, 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:

南方医科大学南方医院 

Applicant's institution:

Nanfang Hospital, Southern Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

南方医科大学南方医院消化内科 

Primary sponsor:

Department of Gastroenterology, Nanfang Hospital, Southern Medical University 

研究实施负责(组长)单位地址:

广州市广州大道北1838号 

Primary sponsor's address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

广州市广州大道北1838号

Institution
hospital:

Nanfang Hospital, Southern Medical University

Address:

1838 Guangzhou Avenue North, Guangzhou, Guangdong, China

经费或物资来源:

广东省省级科技计划项目 

Source(s) of funding:

Guangdong Provincial Science and Technology Plan Project 

研究疾病:

克罗恩病 

Target disease:

crohn's disease 

研究疾病代码:

K50.900 

Target disease code:

K50.900 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

研究英夫利昔单抗单用和联合治疗克罗恩病及抗英夫利昔单抗抗体关系 

Objectives of Study:

study the relationship between infliximab or combinate with azathioprine in treatment of Crohn's disease and relationship with anti-infliximab antibody 

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:

(i)与IFX和AZA或IFX单独联合治疗至少6个月的CD(ii)在0,2,6,14,22,30周测试5mg / kg剂量的IFX治疗并测试TRL在第4周输注IFX之前第14周,ATI,肿瘤坏死因子α。 (iii)AZA治疗应与2mg / kg剂量的IFX同时使用。(iv)输注IFX 6次后,每8周继续定期IFX治疗或每天持续AZA或两者。 

Inclusion criteria

1. CD under combination therapy with IFX and AZA or IFX alone for at least 6 months; 2. scheduled IFX treatment at a dose of 5 mg/kg at week 0,2,6,14, 22, 30 weeks and test TRL, ATI ,TNF-a at week 14 before the fourth time of IFX infusion; 3. AZA treatment should be concomitant with IFX at a dose of 2mg/kg; 4. after 6 times of IFX infusion, continuation of scheduled IFX treatment every 8 weeks or AZA everyday or both of them. 

排除标准:

(i)患者因各种原因停止治疗,停止治疗或拒绝接受相关治疗或接受其他治疗。 (ii)其他疾病在治疗期间发生,与克罗恩病无关,可能影响治疗(iii)本研究中的不完整随访工作 

Exclusion criteria:

1. The patient discontinues treatment for various reasons, stops treatment or refuses to receive relevant treatment or receives other treatments; 2. Other diseases occur during treatment and are not related to Crohn's disease, may affect treatment; 3. Unable to complete the follow-up. 

研究实施时间:

Study execute time:

From2016-01-01To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2016-01-01To 2017-12-31 

干预措施:

Interventions:

组别:

Group 2

样本量:

41

Group:

Group 2

Sample size:

干预措施:

英夫利昔单抗单+硫唑嘌呤

干预措施代码:

Intervention:

infliximab + azathioprine

Intervention code:

组别:

Group 1

样本量:

45

Group:

Group 1

Sample size:

干预措施:

英夫利昔单抗单用

干预措施代码:

Intervention:

infliximab alone

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三甲医院 

Institution
hospital:

Nanfang Hospital, Southern Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

抗英夫利昔单抗抗体

指标类型:

主要指标 

Outcome:

antibody to infliximab

Type:

Primary 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 12 years
最大 Max age 80 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):

非随机对照研究

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

non-randomized controlled trial

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):

是否共享原始数据:

IPD sharing

是Yes

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):

2019年6月1日,通过发表文章共享原始数据; ResMan

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

June 1st 2019.public database on paper; ResMan

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:

病历记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-12-23
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