No registrations found.
ID
Source
Brief title
Health condition
Inflammatory Bowel Disease, in remission with infliximab treatment.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of patients in remission, 6 months after dose adjustment of IFX
Efficacy of IFX maintenance therapy dosed at 3mg/kg in IBD
Secondary outcome
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
Background summary
N/A
Study objective
Infliximab dose can be tailored based on individual trough levels.
Study design
Follow-up up to 64 weeks.
Intervention
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 (<3µg/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 µg/mL), the IFX dose remains stable.
P.O. Box 1738
J.C. Woude, van der
Molewaterplein 40
Rotterdam 3000 DR
The Netherlands
+31 (0)10 4087611
j.vanderwouden@erasmusmc.nl
P.O. Box 1738
J.C. Woude, van der
Molewaterplein 40
Rotterdam 3000 DR
The Netherlands
+31 (0)10 4087611
j.vanderwouden@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3905 |
| NTR-old | NTR4067 |
| Other | : 2013-002651-15 |