Azathioprine maintenance treatment versus Infliximab maintenance treatment in Crohn's disease patients in remission: a randomized multicenter trial - Azorix-trial
- Conditions
- 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
- Registration Number
- EUCTR2008-001131-35-NL
- Lead Sponsor
- Academic Medical Center, department of Gastroenterology and hepatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method