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

January 5, 2018 updated by: Sixth Affiliated Hospital, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • The Sixth Affiliated Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: infliximab and azathioprine at week 0
infliximab and azathioprine combination at week 0
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.
ACTIVE_COMPARATOR: infliximab and azathioprine at week 14
infliximab and azathioprine combination at week 14
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
loss of response(LOR) rate at one year
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

  • Study Chair: Xiang Gao, doctor, The 6th Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

July 1, 2019

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZSLY-XHNK-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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