Therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease

Therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease - TUMMY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55193

Enrollment

160

Registered

2021-02-03

Start date

2021-05-19

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bowel diseases Inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: age

Design outcomes

Primary

Measure	Time frame
The correlation between vedolizumab trough level and disease activity in IBD patients on maintenance therapy with vedolizumab	—

Secondary

Measure	Time frame
Influence of the following parameters on this correlation: - patient characteristics such as gender, weight, age, smoking status, duration of illness, biological therapy in history, CRP, albumin, Hb, calprotectin. - medications such as immunosuppressants and corticosteroids - vedolizumab dosing frequency The mean vedolizumab trough level in patients with active disease compared to patients in remission 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	—

Measure

Time frame

Influence of the following parameters on this correlation: - patient characteristics such as gender, weight, age, smoking status, duration of illness, biological therapy in history, CRP, albumin, Hb, calprotectin. - medications such as immunosuppressants and corticosteroids - vedolizumab dosing frequency The mean vedolizumab trough level in patients with active disease compared to patients in remission 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

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Countries

Netherlands

Outcome results