Therapeutic drug monitoring of vedolizumab in patients with inflammatory bowel disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28041

Enrollment

160

Registered

2020-08-07

Start date

2020-09-13

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Colitis ulcerosa and Crohn's disease

Interventions

None listed

Eligibility

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 <18 years, induction therapy with vedolizumab (<14 weeks), disabled persons.

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 - quality of life (NRS) 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 <5, SCCAI <5, CRP <5.	—

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 - quality of life (NRS) 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 <5, SCCAI <5, CRP <5.

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Contacts

Public ContactMerve Sivridas

Máxima MC

merve.sivridas@mmc.nl0408889020

Outcome results