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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.
Last refreshed on: 12 December 2020
Main ID:  NCT03393247
Date of registration: 08/07/2017
Prospective Registration: Yes
Primary sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Public title: The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD
Scientific title: The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease:a Randomized, Open Label, Single-center Cohort Study
Date of first enrolment: June 1, 2017
Target sample size: 160
Recruitment status: Unknown status
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Name:     Xiang Gao, MD, PhD
Telephone: 020-38663423
Name:     Jian Tang, master
Telephone: 8613751879964
Name:     Xiang Gao, doctor
Affiliation:  the 6th affiliated hospital of Sun Yat-sen university
Key inclusion & exclusion criteria

Inclusion Criteria:

- CD patients need infliximab and azathioprine combination therapy

Exclusion Criteria:

- patients had lost response to infliximab or azathioprine previously patients intolerable
to infliximab or azathioprine patients need to use 5-Aminosalicylates(5-ASA) patients had
participated to other clinical study in two months

Age minimum: 14 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: infliximab and azathioprine combination at week 0
Drug: infliximab and azathioprine combination at week 14
Primary Outcome(s)
loss of response(LOR) rate at one year [Time Frame: one year]
Secondary Outcome(s)
Mucosal healing(MH)status at one year [Time Frame: one year]
Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year [Time Frame: one year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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