Infliximab dose can be tailored based on individual trough levels.
ID
Bron
Verkorte titel
Aandoening
Inflammatory Bowel Disease, in remission with infliximab treatment.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Number of patients in remission, 6 months after dose adjustment of IFX
Efficacy of IFX maintenance therapy dosed at 3mg/kg in IBD
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
Infliximab dose can be tailored based on individual trough levels.
Onderzoeksopzet
Follow-up up to 64 weeks.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
P.O. Box 1738
J.C. Woude, van der
Molewaterplein 40
Rotterdam 3000 DR
The Netherlands
+31 (0)10 4087611
j.vanderwouden@erasmusmc.nl
Wetenschappers
P.O. Box 1738
J.C. Woude, van der
Molewaterplein 40
Rotterdam 3000 DR
The Netherlands
+31 (0)10 4087611
j.vanderwouden@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3905 |
| NTR-old | NTR4067 |
| Ander register | : 2013-002651-15 |