Azathioprine maintenance treatment versus infliximab maintenance treatment in Crohn’s disease patients in remission (Azorix trial)
Recruiting
- Conditions
- Crohn´s disease in remission
- Registration Number
- NL-OMON21255
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
1. Age between 18 and 80
2. For at least 6 months a stable dose of combination therapy with IFX and AZA or with IFX and 6MP
Exclusion Criteria
1. Failed attempt to quit medication during combination therapy before
2. Abdominal abscesses, fistulas and fluid collections
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The occurrence of relapse - defined as a disease activity with a CDAI score greater than 150 - during the 12 months follow-up period.
- Secondary Outcome Measures
Name Time Method 1. Mucosal healing at 12 months<br /><br>2. Number of treatment failures after 12<br /><br>3. Time to relapse<br /><br>4. HRQOL at 12 months, measured by IBDQ