Inflammatory bowel diseases (Crohn's disease, ulcerative colitis)
Conditions
Interventions
Trade Name: Vedolizumab, Entyvio
Pharmaceutical Form: Injection
Sponsors
Amsterdam UMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age 18 or older; ? Diagnosis of CD or UC; ? Clinical and biochemical remission, all three criteria below need to be fulfilled prior to enrolment: ? Absence of active inflammatory intestinal symptoms, as judged by both patient and physician; ? FCP =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: ? Absence of written informed consent; ? Presence of anti-drug antibodies against vedolizumab; ? Concomitant oral glucocorticosteroid usage; ? Imminent need for IBD-related surgery as judged by the treating clinician; ? Actively draining peri-anal fistula; ? Patients with short bowel syndrome, an ostomy or a symptomatic stricture; ? Active participation in another interventional trial; ? Pregnancy or lactation; ? Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness); ? Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cost-effectiveness of the TDM-guided de-escalation group compared to the standard dosing group over 48 weeks.;Secondary Objective: Proportion of patients with sustained clinical remission (based on Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index), proportion of patients with (sustained) biochemical remission (based on c-reactive protein and fecal calprotectin), pharmacokinetic differences (vedolizumab levels), safety and quality of life ;Primary end point(s): - To evaluate whether the SC vedolizumab ‘TDM-guided de-escalation’ strategy using capillary blood measurements will be cost effective, when compared to the standard dosing regimen. ;Timepoint(s) of evaluation of this end point: 8, 18, 28, 38 and 48 weeks after inclusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Proportion of patients with clinical remission (Harvey-Bradshaw Index (HBI) <5 in CD, Simple Clinical Colitis Activity Index (SCCAI) <4 in UC), 28 and 48 weeks after inclusion; - Proportion of patients with sustained clinical remission (persistent clinical remission from the start of the trial) 28 and 48 weeks after inclusion; - Proportion of patients with biochemical remission (fecal calprotectin (FCP) =250 µg/g and c-reactive protein (CRP) =5 mg/L) 48 weeks after inclusion; - Proportion of patients with combined remission (clinical and biochemical) 48 weeks after inclusion; - Proportion of patients with clinical relapse (HBI =5 in CD or SCCAI =4 in UC for two consecutive weeks) and time to clinical relapse; - Proportion of patients in the intervention group that still is in the TDM-guided de-escalation group 8, 18, 28, 38 and 48 weeks after inclusion; - Number of visits to the emergency room, hospitalization and surgical interventions; - HBI (in CD) or SCCAI (in UC) score and patient-reported outcome measures (PROM) by PRO-2: 8, 18, 28, 38 and 48 weeks after inclusion; - Quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ), EQ-5D-5L); - CRP and FCP 48 weeks after inclusion; - Vedolizumab concentrations. All patients: serum vedolizumab concentrations at screening and 48 weeks after inclusion. Intervention group: vedolizumab capillary concentrations according to schedule (4. Study design); - Formation of anti-drug antibody against vedolizumab at week 24 and 48. - Adverse event rates (including injection site reactions, infections and other adverse events linked to biological therapy).;Timepoint(s) of evaluation of this end point: 8, 18, 28, 38 and 48 weeks after inclusion | — |
Countries
Netherlands
Contacts
Public ContactIBD Trialbureau
Amsterdam UMC
Outcome results
None listed