NCT06584162 Subcutaneous Interval Lengthening of Vedolizumab for Economic Research
| NCT ID | NCT06584162 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Inflammatory Bowel Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-02-09 |
| Primary Completion | 2025-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2023-02-09 with a primary completion date of 2025-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Rationale: Subcutaneous vedolizumab is an effective maintenance therapy for patients with inflammatory bowel disease. Patients using subcutaneous vedolizumab (every 2 weeks) have higher vedolizumab serum trough concentrations than those who are treated with intravenous vedolizumab (every 4-8 weeks). Since biologic therapies such as vedolizumab are expensive, lengthening of the injection interval (de-escalation) is of interest to reduce health care costs. However, maintaining remission while extending vedolizumab injection intervals has not been evaluated yet but represents a critical component of both medical and societal costs. Studies have suggested that higher vedolizumab serum concentrations are associated with superior clinical outcomes. Our strategy is to administer subcutaneous vedolizumab with prolonged intervals using therapeutic drug monitoring, i.e. dose based on vedolizumab concentrations, to reduce medical and societal costs while preserving remission. Objectives: To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring (TDM)-guided de-escalation will be cost-effective, compared to normal dosing regimen in patients with inflammatory bowel disease in remission. The secondary objective is to investigate the efficacy of TDM-guided de-escalation subcutaneous vedolizumab dosing compared to standard dosing. Study design: This is a single-centre, randomized controlled, open-label pilot study. Study population: 40 patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) in steroid-free clinical and biochemical remission with subcutaneous vedolizumab maintenance therapy of 108 mg every other week for at least 6 months. Intervention: Patients will be randomized (1:1) to the 'TDM-guided subcutaneous vedolizumab de-escalation' strategy versus 'standard care' (e.g. continuing standard subcutaneous vedolizumab dosing regimen of 108 mg every other week). Main study parameters/endpoints: Primary endpoint: cost-effectiveness of the TDM-guided de-escalation group compared to the standard dosing group over 48 weeks. Secondary endpoints include: 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 and immunogenicity), safety and quality of life (measured by SIBDQ and EQ-5D-5L).
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Crohn's disease or ulcerative colitis * Clinical and biochemical remission: absence of active inflammatory intestinal symptoms, fecal calprotectin \<250 ug/g and CRP \<5 mg/g, HBI \<5 or SCCAI \<4 * Steroid free remission for at least 6 months whilst being treated with subcutaneous vedolizumab at a stable dose of 108mg every other week. Exclusion Criteria: * Absence of written informed consent; * Presence of anti-drug antibodies against vedolizumab, these levels will be determined in case the vedolizumab concentration is below 1 ug/ml; * 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.
Contact & Investigator
G.R.A.M. D'Haens, MD PhD
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT06584162 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06584162 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06584162 currently recruiting?
Yes, NCT06584162 is actively recruiting participants. Contact the research team at s.i.anjie@amsterdamumc.nl for enrollment information.
Where is the NCT06584162 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06584162 clinical trial?
NCT06584162 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is G.R.A.M. D'Haens, MD PhD at Amsterdam UMC. The trial plans to enroll 40 participants.