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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 14 January 2019
Main ID:  ChiCTR1800020305
Date of registration: 2018-12-23
Prospective Registration: No
Primary sponsor: Department of Gastroenterology, Nanfang Hospital, Southern Medical University
Public title: A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease
Scientific title: Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI
Date of first enrolment: 2016-01-01
Target sample size: Group 2:41;Group 1:45;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=34054
Study type:  Observational study
Study design:  Non randomized control  
Phase:  Retrospective study
Countries of recruitment
China
Contacts
Name: Aimin Li   
Address:  1838 Guangzhou Avenue North, Guangzhou, Guangdong, China
Telephone: +86 13580317630
Email: lam0725@qq.com
Affiliation:  Nanfang Hospital, Southern Medical University
Name: Yier Zhao   
Address:  1838 Guangzhou Avenue North, Guangzhou, Guangdong, China
Telephone: +86 13246820732
Email: zxs19670505@163.com
Affiliation:  Nanfang Hospital, Southern Medical University
Key inclusion & exclusion criteria
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.

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.


Age minimum: 12
Age maximum: 80
Gender: Both
Health Condition(s) or Problem(s) studied
crohn's disease
K50.900
Intervention(s)
Group 2:infliximab + azathioprine;Group 1:infliximab alone;
Primary Outcome(s)
antibody to infliximab;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Guangdong Provincial Science and Technology Plan Project
Secondary Sponsor(s)
Ethics review
Status: Not approved
Approval date: 26/08/2013
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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