Synergistic Effect of Vedolizumab and Pentoxifylline

Study Overview
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Brief Summary
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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.

Official Title
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Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: vedolizumab
* Drug: Pentoxifylline
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings Patients who are good candidates to start standard dosing of vedolizumab Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion Exclusion Criteria: Contraindications or history of allergy to PTX Known interaction of PTX with patient's current medications Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion Pregnancy GFR <30 at any time in the 6 months prior to first infusion of VDZ Documented cirrhosis Age <18 or >80 years old Contraindication to colonoscopy at 24 week study time-point

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vedolizumab plus pentoxifylline<br>Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily. | Drug: vedolizumab<br>* standard of care<br>* Other names: Entyvio;Drug: Pentoxifylline<br>* added to vedolizumab<br>* Other names: Trental;|
| Placebo Comparator: vedolizumab plus placebo<br>Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily. | Drug: vedolizumab<br>* standard of care<br>* Other names: Entyvio;Drug: placebo<br>* added to vedolizumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of patients in clinical remission |  | week 14 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | week 24 | 
| number of episodes of myelosuppression |  | week 24 |