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| ID | Type | Description | Link |
|---|---|---|---|
| VEDO-IISR-2014-100892 | Other Identifier | Takeda |
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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to characterize which patients with Crohn's disease are likely to respond to standard of care to vedolizumab therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's disease (CD) | People with CD recently receiving vedolizumab as standard of care will be followed up to 5 years. | ||
| Ulcerative colitis (UC) | People with UC recently receiving vedolizumab as standard of care will be followed up to 5 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| T cell concentration | Evaluated from peripheral blood samples and lamina propria biopsies | up to 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effector memory T cells concentration | Evaluated from peripheral blood samples and lamina propria biopsies | up to 22 weeks |
| T regulatory cells concentration | Evaluated from peripheral blood samples and lamina propria biopsies |
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Inclusion criteria:
Male or Female ≥18 and ≤70 years old.
Patients must be appropriate for baseline colonoscopy prior to induction therapy with vedolizumab.
Patients must have active inflammatory disease as seen by colonoscopy. 3A-Adult patients with moderately to severely active UC who have:
had an inadequate response with, lost response to, or were;
intolerant to a tumor necrosis factor (TNF) blocker or;
immunomodulator; or had an inadequate response with, were;
intolerant to, or demonstrated dependence on corticosteroids:
had an inadequate response with, lost response to, or were
intolerant to a TNF blocker or immunomodulator; or had an
inadequate response with, were intolerant to, or demonstrated
dependence on corticosteroids:
Patients will also have biochemical analysis with CRP and fecal calprotectin prior to initiating treatment with vedolizumab.
Exclusion criteria:
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Participants being seen at the University of Miami IBD clinics with a diagnosis of CD or UC and about to initiate standard of care treatment with vedolizumab.
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| Name | Affiliation | Role |
|---|---|---|
| Maria T Abreu, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| up to 22 weeks |
| D003092 | Colitis |
| D003108 | Colonic Diseases |