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

Recruiting

• Conditions: Crohn's disease; inflammatory bowel disesae; 10017969

• Registration Number: NL-OMON50386
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

Adult anti-TNF therapy naïve luminalCrohn*s disease patients in whom with
vedolizumab therapy is initiated

Exclusion Criteria

Hospitalized patients or patients in need of surgery
Active perianal disease
Prior biological use

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To identify biomarkers predicting response to vedolizumab in patients with CD </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Clinical response at 20 weeks, after induction therapy with vedolizumab<br /><br>defined as a reduction in the Harvey Bradshaw Index (HBI) score of at least 3<br /><br>points<br /><br>-To gain insight in pathways, associated with (non)reponse to vedolizumab in<br /><br>patients with CD<br /><br>-Remission at 20 weeks, defined as a HBI < 4<br /><br>-Sustained clinical benefit at 52 weeks, i.e. persistent clinical improvement<br /><br>under vedolizumab treatment during follow-up without need for new courses of<br /><br>corticosteroids or any other systemic drug (azathioprine, methotrexate,<br /><br>anti-TNF or investigational drugs), or surgery<br /><br>-Molecular handprint defining response to therapy<br /><br>-Calprotectin < 100 mg/mL at 1 year<br /><br>-CRP< 5 mg/mL at 1 year<br /><br>-HBI at 1 year<br /><br>-Change in IBDQ and EQ5D</p><br>