The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD

Crohn Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393247
• Other study ID #: ZSLY-XHNK-03
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2017
• Last updated: January 5, 2018
• Start date: June 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2017
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jian Tang, master
• Phone: 8613751879964
• Email: tangjiansys[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aim to identify the therapeutic effect of azathioprine during infliximab(IFX) treatment in Crohn`s disease (CD).Half of patients will receive azathioprine and infliximab combination therapy at the same time. The other half patients will be given infliximab therapy first and then receive azathioprine 14 weeks later.

Description:

Anti-tumor necrosis factor agents were widely used for many years and were proved to be most reliable drugs in Crohn`s disease (CD). About one-third of the patients would develop a secondary lost of response after initiating IFX therapy in one year follow-up. Immunosuppressor was thought to be a useful agent to reduce loss of response rate of infliximab.But It remain unclear when should us add immunosuppressor during infliximab therapy.This study aim to find the most valuable timepoint to initiate combination therapy to maximize therapeutic effect and minimize the adverse effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• infliximab and azathioprine combination at week 0
All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Experimental group will receive azathioprine at week 0.
• infliximab and azathioprine combination at week 14
All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Control group will receive azathioprine at week 14.

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	loss of response(LOR) rate at one year	LOR was defined as recurrence or worsening of symptoms after achieving remission or response that required IFX dose intensification, addition of concomitant therapy, or discontinuation of IFX.	one year
Secondary	Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year	Patients will undergo colonscopy at one year after infliximab therapy and SES-CD which is a useful ool in evaluating endoscopic activities will be evaluated by colonoscopists.	one year
Secondary	Mucosal healing(MH)status at one year	Patients will undergo colonscopy at one year after infliximab therapy and mucosal healing(MH)means no ulcer in terminal ileum and colorectum.	one year