NCT03393247

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-07-01
• Completion: 2019-07-01
• First posted: 2018-01-08
• Last updated: 2018-01-08

Locations

1 site across 1 country: China