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van CCT (UK)


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van CCT (UK)


Adjusting infliximab dose in patients with inflammatory bowel disease, based on blood levels.


- candidate number15106
- NTR NumberNTR4067
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jul-2013
- Secondary IDs2013-002651-15 
- Public TitleAdjusting infliximab dose in patients with inflammatory bowel disease, based on blood levels.
- Scientific TitleAdjusting infliximab dose in IBD patients in remission, based on infliximab trough levels: the study on Infliximab Levels in IBD patients Steering Treatment, the ILIST pilot
- ACRONYMILIST
- hypothesisInfliximab dose can be tailored based on individual trough levels.
- Healt Condition(s) or Problem(s) studiedInflammatory bowel disease, Infliximab
- Inclusion criteria1. 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 g/g
6. Permitted concomitant therapy: aminosalicylates, thiopurines and methotrexate at stable dose for at least 12 weeks
- Exclusion criteria1. 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)
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate31-dec-2014
- Target number of participants40
- InterventionsIFX 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 (<3g/mL), the IFX dose is reduced to 3mg/kg in case of 5mg/kg, or to 5 mg/kg in case of 10 mg kg. If IFX trough levels are normal (0 3 g/mL), the IFX dose remains stable.
- Primary outcomeNumber of patients in remission, 6 months after dose adjustment of IFX Efficacy of IFX maintenance therapy dosed at 3mg/kg in IBD
- Secondary outcomeNumber 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
- TimepointsFollow-up up to 64 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.C. Woude, van der
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Woude, van der
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD11-jul-2013 - 22-jul-2013


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