The Bullseye study X
- Conditions
- Crohn's disease
- Registration Number
- NL-OMON25264
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
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
oHBI > 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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify biomarkers predicting response to vedolizumab in patients with CD
- Secondary Outcome Measures
Name Time Method To gain insight in pathways, associated with (non)response to vedolizumab in patients with CD