Therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease

Completed

• Conditions: chronic bowel diseases; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON55193
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

age *18 years, maintenance therapy of vedolizumab (>14 weeks), diagnosed with
Crohn's disease (DBC 601) or colitis ulcerosa (DBC602)

Exclusion Criteria

age <18 years, induction therapy with vedolizumab (<14 weeks), incapable of
consenting

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The correlation between vedolizumab trough level and disease activity in IBD<br /><br>patients on maintenance therapy with vedolizumab</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Influence of the following parameters on this correlation:<br /><br>- patient characteristics such as gender, weight, age, smoking status, duration<br /><br>of illness, biological therapy in history, CRP, albumin, Hb, calprotectin.<br /><br>- medications such as immunosuppressants and corticosteroids<br /><br>- vedolizumab dosing frequency<br /><br>The mean vedolizumab trough level in patients with active disease compared to<br /><br>patients in remission<br /><br>The cut-off value for an effective vedolizumab trough level (including positive<br /><br>and negative predictive value). The patient is considered adequately treated<br /><br>with an HBI <5, SCCAI <2, CRP <5.</p><br>