Crohn's disease and ulcerative colitis inflammatory bowel diseases
Conditions
Interventions
Based on concentration measurements, the injection interval will be adjusted to
every 2, 3 or 4 weeks. During screening, a serum concentration measurement will
be performed in all patients, followed
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients with inflammatory bowel diseases in remission on a stable dose of subcutaneous vedolizumab
Exclusion criteria
Exclusion criteria: presence of anti-drug antibodies against vedolizumab, usage of glucocorticosteroid, active draining peri-anal fistula or imminent need for IBD-related surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate whether de-escalating subcutaneous vedolizumab using concentration measurements will be cost-effective compared to the standard dosing regimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical remission, biochemical remission, number of patients with exacerbation, quality of life, CRP and faecal calprotectin, pharmacokinetic aspects, side effect profile and safety. | — |
Countries
Netherlands
Outcome results
None listed