No registrations found.
ID
Source
Brief title
Health condition
Colitis ulcerosa and Crohn's disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation between vedolizumab trough level and disease activity in IBD patients on maintenance therapy with vedolizumab
Secondary outcome
Influence of the following parameters on this correlation:
- patient characteristics such as gender, weight, age, smoking status, duration of illness, biological therapy in history, CRP, albumin, Hb, calprotectin.
- medications such as immunosuppressants and corticosteroids
- vedolizumab dosing frequency
- quality of life (NRS)
The mean vedolizumab trough level in patients with active disease compared to patients in remission
The cut-off value for an effective vedolizumab trough level (including positive and negative predictive value). The patient is considered adequately treated with an HBI <5, SCCAI <5, CRP <5.
Background summary
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.
Study objective
The hypothesis is that higher vedolizumab through levels correlate with better disease management
Study design
One point measurement
Inclusion criteria
age ≥18 years, maintenance therapy of vedolizumab (>14 weeks), diagnosed with Crohn's disease (DBC 601) or colitis ulcerosa (DBC602)
Exclusion criteria
age <18 years, induction therapy with vedolizumab (<14 weeks), disabled persons.
Design
Recruitment
IPD sharing statement
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 | NL8820 |
Other | METC Máxima MC : To be assisgned |