A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study
- Conditions
- 10017969Crohn's Disease
- Registration Number
- NL-OMON36566
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 906
18 years or older
- Mesalazine maintenance therapy >1 year
- Quiescent disease (definition: CDAI <150)
- Written informed consent
- Flare-up(s) of CD within 12 months preceding inclusion
- Treatment with prednisone, budesonide, infliximab, adalumimab of ceroluzimab within 12 months of inclusion
- Treatment with methotrexate, mercaptopurine or azathioprine, when initiated within 6 months prior to inclusion
- Extra-intestinal CD manifestations such as fistulas or pyoderma gangrenosum demanding induction therapy
- Treatment with enteral or parenteral feeding within 6 months prior to inclusion
- Treatment with metronidazole, ciprofloxacin, rectal steroids or rectal aminosalicylates within 12 months prior to inclusion
- Previous ileo-colorectal resection, such as small bowel resections >100 cm, total proctocolectomy, subtotal colectomy, colostomy or ileostomy
- Primary sclerosing cholangitis (PSC)
- Hypersensitivity to mesalazine
- Disorders, which are likely to require systemic steroids (e.g. asthma)
- Abnormalities in liver function tests (definition: 2x upper limit of normal value of ALAT. Normal values ALAT: > 45 U/L (men) of >35 U/L (women)
- Abnormalities in kidney function tests (definition: creatinin > 120 µmol/L (men) or
>103 µmol/L (women)
- Dysplasia or neoplasia of the colon
- Pregnant or lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Proportion of patients who experience a clinical relapse during the 18<br /><br>months follow-up period, defined as:<br /><br>- CDAI score above 250 or a score between 150-250 in 3 consecutive weeks with<br /><br>an increase of at least 75 points above the baseline value;<br /><br>- Need to perform surgery;<br /><br>- Adjustment of CD-related therapy during follow-up, for example by the<br /><br>addition of steroids, infliximab, methotrexate, 6-mercaptopurine or<br /><br>azathioprine.<br /><br><br /><br>2. Cost-effectiveness will be assessed. </p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Quality of life, to be measured using the quality of life questionnaires<br /><br>(IBDQ and the SF-36).<br /><br><br /><br>2. Compliance to therapy, which will be established by measuring urinary<br /><br>concentrations of mesalazine and its metabolite N-acetyl-5-ASA at T=6 and<br /><br>T=18. </p><br>