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

Recruiting

Conditions: Crohn's disease
inflammatory bowel disesae
10017969

Registration Number: NL-OMON54895

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion 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 naive or exposed (infliximab and/or adalimumab)

Exclusion Criteria

- 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
<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 defined<br /><br>as a reduction in the Harvey Bradshaw Index (HBI) score of at least 3 points<br /><br>-To gain insight in pathways, associated with (non)reponse to vedolizumab in<br /><br>patients with CD -Remission at 20 weeks, defined as a HBI < 4 -Sustained<br /><br>clinical benefit at 52 weeks, i.e. persistent clinical improvement under<br /><br>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 -Molecular handprint defining<br /><br>response to therapy -Calprotectin < 100 mg/mL at 1 year -CRP< 5 mg/mL at 1 year<br /><br>-HBI at 1 year -Change in IBDQ and EQ5D</p><br>