IBD Inflammatory Bowel disease
Conditions
Interventions
Patients in the intervention arm will receive individualized treatment with
variable IFX dosing AND/OR intervals guided by a Bayesian pharmacokinetic
model, aiming to achieve an IFX TL of 3 µg/ml. P
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Diagnosis of CD or UC based on endoscopy and pathology 18 years or older Clinical remission, based on a Harvey Bradshaw Index (HBI) score *4 or a Partial Mayo (PM) score *2, for CD and UC Scheduled IFX maintenance treatment, regardless of interval/dosing
Exclusion criteria
Exclusion criteria: A history of stenotic IBD requiring dilatation and or resectional surgery in the past year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Proportion of patients with sustained clinical remission (based on HBI or PM). Secondary endpoints include: annual costs of IFX treatment per patient, total annual medical costs, side effects, (sustained) biochemical remission, adverse events, quality of life, IFX trough level and IFX antibodies (with an assay allowing presence of drug). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include: annual costs of IFX treatment per patient, total annual medical costs, side effects, (sustained) biochemical remission, adverse events, quality of life, IFX trough level and IFX antibodies (with an assay allowing presence of drug). | — |
Countries
Netherlands
Outcome results
None listed