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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on Crohn Disease：a Randomized, Open Label, Single-center Cohort Study

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: infliximab and azathioprine combination at week 0
* Drug: infliximab and azathioprine combination at week 14


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: infliximab and azathioprine at week 0<br>infliximab and azathioprine combination at week 0 | Drug: infliximab and azathioprine combination at week 0<br>* 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.<br>|
| Active Comparator: infliximab and azathioprine at week 14<br>infliximab and azathioprine combination at week 14 | Drug: infliximab and azathioprine combination at week 14<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infliximab, azathioprine