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

Primary Purpose

Crohn Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

infliximab and azathioprine combination at week 0

infliximab and azathioprine combination at week 14

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring infliximab, azathioprine

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

infliximab and azathioprine at week 0

infliximab and azathioprine at week 14

Arm Description

infliximab and azathioprine combination at week 0

infliximab and azathioprine combination at week 14

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03393247

First Posted

July 8, 2017

Last Updated

January 5, 2018

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03393247

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

July 1, 2018 (Anticipated)

Study Completion Date

July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

Keywords

infliximab, azathioprine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

infliximab and azathioprine at week 0

Arm Type

Active Comparator

Arm Description

infliximab and azathioprine combination at week 0

Arm Title

infliximab and azathioprine at week 14

Arm Type

Active Comparator

Arm Description

infliximab and azathioprine combination at week 14

Intervention Type

Drug

Intervention Name(s)

infliximab and azathioprine combination at week 0

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

infliximab and azathioprine combination at week 14

Intervention Description

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.

Primary Outcome Measure Information:

Title

loss of response(LOR) rate at one year

Description

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

Secondary Outcome Measure Information:

Title

Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year

Description

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

Title

Mucosal healing（MH）status at one year

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jian Tang, master

Phone

8613751879964

tangjiansys@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiang Gao, doctor

Organizational Affiliation

the 6th affiliated hospital of Sun Yat-sen university

Official's Role

Study Chair

Facility Information:

Facility Name

The Sixth Affiliated Hospital, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiang Gao, MD, PhD

Phone

020-38663423

helengao818@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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