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Main
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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. |
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Register:
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ChiCTR |
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Last refreshed on:
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14 January 2019 |
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Main ID: |
ChiCTR1800020305 |
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Date of registration:
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2018-12-23 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A follow-up study for infliximab or combine with azathioprine in the treatment of Crohn's disease
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Scientific title:
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Infliximab or combine with azathioprine in the treatment of Crohn's disease and relationship with ATI |
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Date of first enrolment:
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2016-01-01 |
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Target sample size:
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Group 2:41;Group 1:45; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=34054 |
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Study type:
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Observational study |
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Study design:
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Non randomized control
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Phase:
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Retrospective study
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Countries of recruitment
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China
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Contacts
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Name:
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Yier Zhao
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Address:
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1838 Guangzhou Avenue North, Guangzhou, Guangdong, China
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Telephone:
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+86 13246820732 |
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Email:
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zxs19670505@163.com |
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Affiliation:
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Nanfang Hospital, Southern Medical University |
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Name:
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Aimin Li
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Address:
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1838 Guangzhou Avenue North, Guangzhou, Guangdong, China
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Telephone:
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+86 13580317630 |
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Email:
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lam0725@qq.com |
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Affiliation:
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Nanfang Hospital, Southern Medical University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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K50.900
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crohn's disease
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Intervention(s)
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Group 2:infliximab + azathioprine;Group 1:infliximab alone;
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Primary Outcome(s)
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antibody to infliximab;
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Source(s) of Monetary Support
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Guangdong Provincial Science and Technology Plan Project
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Ethics review
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Status: Not approved
Approval date: 26/08/2013
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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