*Cellular parameters predict favourable response treatment with vedolizumab?*
- Conditions
- Crohn's disease and cell characteristics10017969
- Registration Number
- NL-OMON42625
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;1. Male and female patients with CD, aged > 18 years;
2. Perianal disease;
3. Initiating vedolizumab for approved indications (moderately to severely active Crohn*s Disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF* antagonist);
4. Signed informed consent and medical records release by the patient or a legally acceptable representative.
* No informed consent
* Insufficient knowledge of Dutch language and/or inability to
understand the information provided
* active proctitis
* Hypersensitivity to the active substance or to any of the following
excipients: L-histidine; L-histidine monohydrochloride; L-arginine hydrochloride; sucrose and polysorbate 80
* Active severe infections such as tuberculosis, sepsis,
cytomegalovirus, listeriosis, and opportunistic infections such as Progressive Multifocal Leukoencephalopathy (PML) (see section 4.4. in SmPC).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Determine if the immune and/or stromal cell status prior to the application<br /><br>of vedolizumab correlates with response to treatment.<br /><br>2. Determine which changes in cellular parameters correspond to favourable<br /><br>response to treatment with vedolizumab.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Use this information to design an optimized patient inclusion protocol for the<br /><br>use of vedolizumab for treatment of Crohn*s disease.</p><br>