A trial to determine if vedolizumab ( medication) can prevent Crohn's disease return better than a placebo after a surgical resection of the sick bowel.
Phase 4
Completed
- Conditions
- <tr><td>Crohn's disease</td></tr>Inflammatory bowel disease10017969
- Registration Number
- NL-OMON24487
- Lead Sponsor
- Academic Medical Center, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria
1. Patients that need to continue postoperative medication for their CD as per investigator's discretion, eg for fistulizing perianal CD.
2. Previous treatment with VDZ
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of patients with clinically significant endoscopic recurrence (Rutgeerts i2b, i3 or i4) at week 26.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Proportion of patients without endoscopic recurrence (i0)<br /><br>- Symptomatic recurrence (CDAI increase >70 points compared to baseline)<br /><br>- Proportion of patients with normalized serum CRP at all time points and CRP at all visits<br /><br>- Proportion of patients with normal fecal calprotectin (<50) at all visits<br /><br>- Quality of life measured by IBDQ and SF-36<br /><br>- Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion</p><br>