Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-001131-35-NL
• Date of registration: 29/05/2008
• Prospective Registration: No
• 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
• 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

Countries of recruitment

Netherlands

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)

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

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 ID(s)

08-0106-stop