Lengthening the time between vedolizumab injections for cost savings

Subcutaneous Vedolizumab Drug De-escalation Using Therapeutic Drug Monitoring in Inflammatory Bowel Disease: a Randomized Controlled Pilot Study

This study is testing if people with Crohn's disease and ulcerative colitis can safely go longer between their vedolizumab injections while still staying healthy and saving money.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: vedolizumab
• Locations: 1 site (Amsterdam)
• Trial ID: NCT06584162 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of extending the interval between subcutaneous vedolizumab injections for patients with inflammatory bowel diseases, specifically Crohn's disease and ulcerative colitis. By using therapeutic drug monitoring to adjust dosing based on vedolizumab serum concentrations, the study aims to maintain clinical remission while potentially reducing healthcare costs associated with biologic therapies. The approach focuses on patients who are already in remission and have been stable on their current treatment regimen. The ultimate goal is to determine if longer intervals between injections can be safely implemented without compromising patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Crohn's disease or ulcerative colitis who are in clinical and biochemical remission on a stable dose of subcutaneous vedolizumab.

Not a fit: Patients who are actively experiencing disease symptoms, require surgery, or have other significant medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the financial burden of treatment for patients with inflammatory bowel diseases while maintaining effective disease management.

How similar studies have performed: While the concept of adjusting biologic therapy intervals is being explored, this specific approach using vedolizumab and therapeutic drug monitoring is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Amsterdam

• Amsterdam UMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Principal investigator: G.R.A.M. D'Haens, MD PhD — Amsterdam UMC
• Study coordinator: Suzanne Anjie, MD

Conditions Inflammatory Bowel Diseases