Crohn's disease and cell characteristics
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: * 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Determine if the immune and/or stromal cell status prior to the application of vedolizumab correlates with response to treatment. 2. Determine which changes in cellular parameters correspond to favourable response to treatment with vedolizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Use this information to design an optimized patient inclusion protocol for the use of vedolizumab for treatment of Crohn*s disease. | — |
Countries
Netherlands
Outcome results
None listed