A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study.
- Conditions
- MesalazineCrohn's DiseaseRelapse rateCosts reduction
- Registration Number
- NL-OMON28798
- Lead Sponsor
- B. Oldenburg, MD, PhD Department of Gastroenterology and HepatologyUniversity Medical Center UtrechtP.O. Box 85500, 3508 GA UtrechtHeidelberglaan 100, 3584 CX UtrechtTel.nr.: +31 887555555 Fax.nr.: +31 88 755 5533E-mail: boldenbu@umcutrecht.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 906
Inclusion Criteria
1. 18 years or older;
2. Mesalazine maintenance therapy >1 year;
Exclusion Criteria
1. Flare-up(s) of CD within 12 months preceding inclusion;
2. Treatment with prednisone, budesonide, infliximab, adalumimab of ceroluzimab within 12 months of inclusion;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of patients who experience a clinical relapse during the 18 months follow-up period, defined as:<br /><br>A. CDAI score above 250 or a score between 150-250 in 3 consecutive weeks with an increase of at least 75 points above the baseline value;<br /> <br>B. Need to perform surgery;<br /><br>C. Adjustment of CD-related therapy during follow-up, for example by the addition of steroids, infliximab, methotrexate, 6-mercaptopurine or azathioprine. <br /><br>2. Cost-effectiveness will be assessed.
- Secondary Outcome Measures
Name Time Method 1. Quality of life, to be measured using the quality of life questionnaires (IBDQ and the SF-36);<br /><br>2. Compliance to therapy, which will be established by measuring urinary concentrations of mesalazine and its metabolite N-acetyl-5-ASA at T=6 and T=18.