The hypothesis is that higher vedolizumab through levels correlate with better disease management
ID
Bron
Verkorte titel
Aandoening
Colitis ulcerosa and Crohn's disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The correlation between vedolizumab trough level and disease activity in IBD patients on maintenance therapy with vedolizumab
Achtergrond van het onderzoek
edolizumab is often used in inflammatory bowel diseases after failure of anti-TNF therapy. In anti-TNF therapy, in particular infliximab, reactive therapeutic drug monitoring is already extensively used, ie in therapy failure or sub-optimal therapy. This involves monitoring anti-TNF trough levels and anti-TNF antibodies to optimize therapy. Vedolizumab is used in a standard dose of 300 mg at weeks 0, 2 and 6 as induction, after that the therapy is switched to maintenance therapy of 300 mg every 8 weeks. In addition, in the regular treatment protocol for Crohn's patients with a reduced response, the possibility is given to administer an extra dose at week 10. Also, after induction, the treatment frequency can be shortened to every 4 weeks when patients show a reduced response in both Crohn's disease and ulcerative colitis. Various studies show that there is a concentration effect relationship in vedolizumab therapy. Despite indications in the literature, this is not yet standard practice in the hospital. The use of therapeutic drug monitoring of vedolizumab in the treatment of inflammatory bowel disease has the potential to individualize and optimize this treatment. The aim of this study is to determine whether there is a correlation between vedolizumab trough level and disease activity in a typical IBD population. In addition, the extent to which patient characteristics and co-medication influence the trough level and thus possibly the disease activity is also examined. Finally, if a correlation exists, an attempt will be made to define a cut-off value.
Doel van het onderzoek
The hypothesis is that higher vedolizumab through levels correlate with better disease management
Onderzoeksopzet
One point measurement
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
age ≥18 years, maintenance therapy of vedolizumab (>14 weeks), diagnosed with Crohn's disease (DBC 601) or colitis ulcerosa (DBC602)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
age <18 years, induction therapy with vedolizumab (<14 weeks), disabled persons.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
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NTR-new | NL8820 |
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