A randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study

• Conditions: 1. Patients with a diagnosis of quiscent (CDAI < 150) Crohn's Disease (CD) according to established clinical, endoscopic, radiological and histological criteria. 2. Patients will be aged 18 years or older. 3. Patients with mesalazine maintenance therapy > 1 year.; MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease

• Registration Number: EUCTR2009-011220-62-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 18 years or older
- Mesalazine maintenance therapy >1 year
- Quiescent disease (definition: CDAI <150)
- Written informed consent
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

- 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 clinical trial of medicinal product
• Study Design: Not specified