No registrations found.
ID
Source
Health condition
Inflammatory Bowel Diseases; Crohn's Disease; Ziekte van Crohn; Chronische darmontsteking; Inflammatoire darmziekten; vedolizumab; Entyvio; systems medicine
Sponsors and support
Intervention
Outcome measures
Primary outcome
To identify biomarkers predicting response to vedolizumab in patients with CD
Secondary outcome
To gain insight in pathways, associated with (non)reponse to vedolizumab in patients with CD
Background summary
See hypothesis.
Study objective
Crohn's disease is an immune-mediated disease that results in chronic inflammation in genetically predisposed individuals exposed to an appropriate environment. The introduction of monoclonal antibodies has revolutionized the treatment of Crohn’s disease (CD). Unfortunately, the efficacy of these agents is hampered by loss of response in a significant proportion of patients. Recently, vedolizumab, an integrin á4â7 antagonist, has been licensed for the treatment of CD and UC. Response rates vary between 31% for CD and 47% for UC at week 6 (1;2). In biological-naive patients, response rates may be up to 40% at week 6 and 47% at week 10 (unpublished results from Gemini 2 en 3 studies). However, a considerable proportion of patients does not respond to vedolizumab. Since the use of vedolizumab is associated with substantial financial expenditures, tools to identify patients in whom the drug will be effective are warranted.
Hypothesis:
Response and non-response to vedolizumab can be predicted using biomarkers, identified through a System Medicine approach.
Study design
Prior to starting therapy; week 2, week 6, week 22, week 52
Intervention
Vedolizumab therapy
Heidelberglaan 100, Postbus 85500
Utrecht 3508 GA
The Netherlands
088-8555555
j.p.d.schultheiss-7@umcutrecht.nl
Heidelberglaan 100, Postbus 85500
Utrecht 3508 GA
The Netherlands
088-8555555
j.p.d.schultheiss-7@umcutrecht.nl
Inclusion criteria
Adult CD patients with luminal disease, who are anti-TNF therapy naïve, with an indication for step-up to vedolizumab will be recruited.
Exclusion criteria
- No consent to participate in the study
- Hospitalized patients or patients in need of surgery
- Active perianal disease
- Prior biological use
- Recent use of antibiotics (within 4 weeks of baseline)
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6439 |
| NTR-old | NTR7229 |
| CCMO | NL60968.041.17 |
| OMON | NL-OMON50386 |