Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study

Phase 4

Recruiting

• Conditions: Crohn's disease and ulcerative colitis; inflammatory bowel diseases; 10017969

• Registration Number: NL-OMON51420
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

patients with inflammatory bowel diseases in remission on a stable dose of
subcutaneous vedolizumab

Exclusion Criteria

presence of anti-drug antibodies against vedolizumab, usage of
glucocorticosteroid, active draining peri-anal fistula or imminent need for
IBD-related surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate whether de-escalating subcutaneous vedolizumab using concentration<br /><br>measurements will be cost-effective compared to the standard dosing regimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical remission, biochemical remission, number of patients with<br /><br>exacerbation, quality of life, CRP and faecal calprotectin, pharmacokinetic<br /><br>aspects, side effect profile and safety.</p><br>