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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
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.
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.
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGloss 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.
Time frame: one year
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.
Time frame: one year
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.
Time frame: one year
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