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| Name | Class |
|---|---|
| Takeda | INDUSTRY |
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The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vedolizumab plus pentoxifylline | Experimental | Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily. |
|
| vedolizumab plus placebo | Placebo Comparator | Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vedolizumab | Drug | standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| proportion of patients in clinical remission | week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| number of new major and minor infections | week 24 | |
| number of episodes of nephrotoxicity | week 24 | |
| number of episodes of hepatotoxicity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amar R Deshpande, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Crohn's and Colitis Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
| D010431 | Pentoxifylline |
| ID | Term |
|---|---|
| D013805 | Theobromine |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pentoxifylline | Drug | added to vedolizumab |
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| placebo | Drug | added to vedolizumab |
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| week 24 |
| number of episodes of myelosuppression | week 24 |
| D007410 | Intestinal Diseases |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |