No registrations found.
ID
Source
Brief title
Health condition
Mesalazine
Crohn's Disease
Relapse rate
Costs reduction
Sponsors and support
Department of Gastroenterology and Hepatology
University Medical Center Utrecht
P.O. Box 85500, 3508 GA Utrecht
Heidelberglaan 100, 3584 CX Utrecht
Tel.nr.: +31 887555555
Fax.nr.: +31 88 755 5533
E-mail: boldenbu@umcutrecht.nl
Intervention
Outcome measures
Primary outcome
1. 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.
Background summary
N/A
Study objective
N/A
Study design
0, 6, 12, 18 months of follow up .
Intervention
Patients 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.
P.O. Box 85500, 3508 GA Utrecht
M.E. Valk, van der
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 887557363
m.e.vandervalk-4@umcutrecht.nl
P.O. Box 85500, 3508 GA Utrecht
M.E. Valk, van der
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 887557363
m.e.vandervalk-4@umcutrecht.nl
Inclusion criteria
1. 18 years or older;
2. Mesalazine maintenance therapy >1 year;
3. Quiescent disease (definition: CDAI <150);
4. Written informed consent.
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;
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 ìmol/L (men) or
>103 ìmol/L (women);
13. Dysplasia or neoplasia of the colon;
14. Pregnant or lactating women.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1787 |
| NTR-old | NTR1897 |
| CCMO | NL29045.041.09 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON36566 |