Inflammatory Bowel Disease, in remission with infliximab treatment.
Conditions
Interventions
IFX trough levels are measured in IBD patients in long term remission. Based on IFX trough levels, the IFX dose may be adjusted. The IFX dosing interval does not change.
If IFX trough levels are high
Sponsors
Erasmus MC Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-70 2. Written informed consent 3. Patients with inflammatory bowel disease (IBD) treated with infliximab (IFX) 4.. In clinical remission for 18 months after initiation of infliximab 5. Fecal calprotectin < 200 µg/g 6. Permitted concomitant therapy: aminosalicylates, thiopurines and methotrexate at stable dose for at least 12 weeks
Exclusion criteria
Exclusion criteria: 1. Concomitant corticosteroid usage 2. Pregnancy or lactation 3. Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients in remission, 6 months after dose adjustment of IFX Efficacy of IFX maintenance therapy dosed at 3mg/kg in IBD | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, in patients with and without dose adjustments Number of patients in remission at 12 months Cost-effectiveness of IFX dose adjustments | — |
Contacts
Public ContactJ.C. Woude, van der
Erasmus Medical Center, Department of General Practice, P.O. Box 1738
Outcome results
None listed