The Therapy Effect of Azathioprine Initial or 14 Weeks After Combined With Infliximab on CD
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 8, 2018
July 1, 2017
1.1 years
July 8, 2017
January 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Simple Endoscopic Score for Crohn's Disease(SES-CD) at one year
one year
Mucosal healing（MH）status at one year
one year
Study Arms (2)
infliximab and azathioprine at week 0
ACTIVE COMPARATORinfliximab and azathioprine combination at week 0
infliximab and azathioprine at week 14
ACTIVE COMPARATORinfliximab and azathioprine combination at week 14
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \- CD patients need infliximab and azathioprine combination therapy
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiang Gao, doctor
the 6th affiliated hospital of Sun Yat-sen university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2017
First Posted
January 8, 2018
Study Start
June 1, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2019
Last Updated
January 8, 2018
Record last verified: 2017-07