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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2008-001131-35-NL
Date of registration: 29/05/2008
Prospective Registration: Yes
Primary sponsor: Academic Medical Center, department of Gastroenterology and hepatology
Public title: Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial
Scientific title: Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial
Date of first enrolment: 14/05/2008
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-001131-35
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no  
Phase: 
Countries of recruitment
Netherlands
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Age > 18
2. At least 6 months a stable dose of combination therapy with AZA and IFX or with 6MP and IFX
3. CD in remission (defined by a CDAI lower than 150 points) for at least 6 months

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Abdominal abscesses, fistulas and fluid collections
2. Co morbidity or extra-intestinal complications that require infliximab treatment
3. Crohn’s disease activity of the upper gastrointestinal tract that requires infliximab treatment
4. Age > 80 years
5. Legally incompetent patients



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
this study is designed as a multicenter radomized trial comparing azathioprine maintenance treatment to infliximab maintenance treatment in Crohn's disease patients that are in remission for at least 6 months while being treated with a combined therapy of infliximab and azathioprine for at least 6 months
Intervention(s)

Trade Name: Remicade
Product Name: Infliximab
Product Code: EU/1/99/116/003
Pharmaceutical Form: Intravenous infusion

Trade Name: Imuran
Product Name: Azathioprine
Product Code: RVG 05565
Pharmaceutical Form: Oral drops*

Primary Outcome(s)
Main Objective: The primary objective of this study is to onvestigate whether Azathioprine maintenance therapy is as effective as infliximab maintenance therapy after remission induction with infliximab/azathioprine combination therapy for at least 6 months. Efficacy is defined as the number of patients suffering from a relapse during the 12 months follow-up
Primary end point(s): Number of patients suffering from a relapse during the 12 months follow up period. A relapse is defined as CDAI (Crohn's disease activity index) > 150.
Secondary Objective: Secondary objectives are to investigate:
- the presence of mucosal healing at 12 months
- the number of treatment failures during the 12 months follow-up period
- time tot relapse
- the patients' level of health related quality of life (hrqol) at the end of the study period
Secondary Outcome(s)
Secondary ID(s)
08-0106-stop
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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