The Bullseye study XL

Towards the identification of molecular pathways predicting response to vedolizumab (Entyvio®) in Crohn’s disease deploying Systems Medicine: the BullsEye Study XL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25264

Enrollment

Registered

2021-03-29

Start date

2021-05-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Crohn's disease

Interventions

This is an observational study. Patients will be treated with vedolizumab as in regular care.

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Confirmed and active Crohn’s disease defined as follows o HBI > 4 and at least 2 of the following ? CRP > 10 ? calprotectine > 150 ? Endoscopic active disease ? Active disease on MRI-enterography - Age > 18 year - Anti-TNF exposed (infliximab and/or adalimumab)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - No consent to participate in the study - Active perianal disease - Prior vedolizumab or ustekinumab therapy - Recent use of antibiotics (within 4 weeks of baseline) - Hospitalised patients or patients in need of surgery

Design outcomes

Primary

Measure	Time frame
To identify biomarkers predicting response to vedolizumab in patients with CD	—

Secondary

Measure	Time frame
To gain insight in pathways, associated with (non)response to vedolizumab in patients with CD	—

Contacts

Public ContactHans-Paul Schultheiss

UMC Utrecht

j.p.d.schultheiss-7@umcutrecht.nl0887550766

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)