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


- candidate number6057
- NTR NumberNTR1897
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-jul-2009
- Secondary IDsNL29045.041.09 2009-011220-62
- Public TitleA randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study.
- Scientific TitleA randomized controlled withdrawal trial in Crohn's disease patients in long-term remission on mesalazine: the CROWN study.
- ACRONYMWithdrawal of mesalazine in Crohn's Disease patients
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedCrohn's disease, Cost-effectiveness , Relapse, Mesalazine
- Inclusion criteria1. 18 years or older;
2. Mesalazine maintenance therapy >1 year;
3. Quiescent disease (definition: CDAI <150);
4. Written informed consent.
- Exclusion criteria1. Flare-up(s) of CD within 12 months preceding inclusion;
2. Treatment with prednisone, budesonide, infliximab, adalumimab of ceroluzimab within 12 months of inclusion;
3. Treatment with methotrexate, mercaptopurine or azathioprine, when initiated within 6 months prior to inclusion;
4. Extra-intestinal CD manifestations such as fistulas or pyoderma gangrenosum demanding induction therapy;
5. Treatment with enteral or parenteral feeding within 6 months prior to inclusion;
6. Treatment with metronidazole, ciprofloxacin, rectal steroids or rectal aminosalicylates within 12 months prior to inclusion;
7. Previous ileo-colorectal resection, such as small bowel resections >100 cm, total proctocolectomy, subtotal colectomy, colostomy or ileostomy;
8. Primary sclerosing cholangitis (PSC);
9. Hypersensitivity to mesalazine;
10. Disorders, which are likely to require systemic steroids (e.g. asthma);
11. 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);
12. Abnormalities in kidney function tests (definition: creatinin > 120 ýmol/L (men) or >103 ýmol/L (women);
13. Dysplasia or neoplasia of the colon;
14. Pregnant or lactating women.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2012
- Target number of participants906
- InterventionsPatients will be randomized in a 1:1 ratio to 18 months of therapy receiving either mesalazine or no treatment. In case of mesalazine treatment, patients will continue their regular treatment. Physicians will be allowed to prescribe any brand of mesalazine (Asacol«, Pentasa«, Salofalk« or generic mesalazine). Dosing of Pentasa« and Salofalk« will be 3 gram once daily. Dosing of Asacol« will be 3.2 gram once daily.
- Primary outcome1. Proportion of patients who experience a clinical relapse during the 18 months follow-up period, defined as:
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;
B. Need to perform surgery;
C. Adjustment of CD-related therapy during follow-up, for example by the addition of steroids, infliximab, methotrexate, 6-mercaptopurine or azathioprine.
2. Cost-effectiveness will be assessed.
- Secondary outcome 1. Quality of life, to be measured using the quality of life questionnaires (IBDQ and the SF-36);
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.
- Timepoints0, 6, 12, 18 months of follow up .
- Trial web sitewww.juliuscentrum.nl/crown
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD-student M.E. Valk, van der
- CONTACT for SCIENTIFIC QUERIESMD, PhD B. Oldenburg
- Sponsor/Initiator University Medical Center Utrecht (UMCU), Department of Gastroenterology and Hepatology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD6-jul-2009 - 6-okt-2009


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