Crohn´s disease in remission
Conditions
Interventions
- Infliximab:
Patients randomly allocated to continuing on IFX mono therapy will continue maintenance treatment with IFX. Comedication by means of AZA or its derivate 6MP will be stopped. Maintenanc
only AZA or 6MP will be continued. If patients received IFX in combination with AZA before randomization they will only continue AZA
if patients received IFX in combination with 6MP they will continue using 6MP. Dosages will be the same as before randomization.
For AZA this will be a dose of 2.5 mg/kg daily
6MP will be continued in a dose of 1,5 mg/kg daily.
Sponsors
Academic Medical Center (AMC)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 2. For at least 6 months a stable dose of combination therapy with IFX and AZA or with IFX and 6MP 3. CD in remission for at least 6 months
Exclusion criteria
Exclusion criteria: 1. Failed attempt to quit medication during combination therapy before 2. Abdominal abscesses, fistulas and fluid collections 3. Comorbidity or extra-intestinal complications that require infliximab treatment 4. Crohn’s disease activity of the upper gastrointestinal tract that requires infliximab treatment 5. Legally incompetent patients
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Mucosal healing at 12 months 2. Number of treatment failures after 12 3. Time to relapse 4. HRQOL at 12 months, measured by IBDQ | — |
Primary
| Measure | Time frame |
|---|---|
| The occurrence of relapse - defined as a disease activity with a CDAI score greater than 150 - during the 12 months follow-up period. | — |
Contacts
Public ContactE.J. Eshuis
Academisch Medisch Centrum Afdeling Chirurgie / MDL Meibergdreef 9, G4-130 Postbus 22660
Outcome results
None listed