The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD
- Conditions
- Crohn Disease
- Interventions
- Registration Number
- NCT03393247
- Lead Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- CD patients need infliximab and azathioprine combination therapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description infliximab and azathioprine at week 0 infliximab and azathioprine combination at week 0 infliximab and azathioprine combination at week 0 infliximab and azathioprine at week 14 infliximab and azathioprine combination at week 14 infliximab and azathioprine combination at week 14
- Primary Outcome Measures
Name Time Method loss of response(LOR) rate at one year 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.
- Secondary Outcome Measures
Name Time Method Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year 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.
Mucosal healing（MH）status at one year one year Patients will undergo colonscopy at one year after infliximab therapy and mucosal healing（MH）means no ulcer in terminal ileum and colorectum.
Trial Locations
- Locations (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China