Therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease
- Conditions
- Colitis ulcerosa and Crohn's disease
- Registration Number
- NL-OMON28041
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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), disabled persons.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation between vedolizumab trough level and disease activity in IBD patients on maintenance therapy with vedolizumab
- Secondary Outcome Measures
Name Time Method Influence of the following parameters on this correlation:<br>- patient characteristics such as gender, weight, age, smoking status, duration of illness, biological therapy in history, CRP, albumin, Hb, calprotectin.<br>- medications such as immunosuppressants and corticosteroids<br>- vedolizumab dosing frequency<br>- quality of life (NRS)<br><br>The mean vedolizumab trough level in patients with active disease compared to patients in remission<br>The cut-off value for an effective vedolizumab trough level (including positive and negative predictive value). The patient is considered adequately treated with an HBI <5, SCCAI <5, CRP <5.