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Synergistic Effect of Vedolizumab and Pentoxifylline

Primary Purpose

Crohn Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
vedolizumab
Pentoxifylline
placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Crohn's and Colitis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vedolizumab plus pentoxifylline

vedolizumab plus placebo

Arm Description

Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.

Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.

Outcomes

Primary Outcome Measures

proportion of patients in clinical remission

Secondary Outcome Measures

number of new major and minor infections
number of episodes of nephrotoxicity
number of episodes of hepatotoxicity
number of episodes of myelosuppression

Full Information

First Posted
October 31, 2016
Last Updated
July 9, 2019
Sponsor
University of Miami
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT02953275
Brief Title
Synergistic Effect of Vedolizumab and Pentoxifylline
Official Title
Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
June 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vedolizumab plus pentoxifylline
Arm Type
Experimental
Arm Description
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.
Arm Title
vedolizumab plus placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.
Intervention Type
Drug
Intervention Name(s)
vedolizumab
Other Intervention Name(s)
Entyvio
Intervention Description
standard of care
Intervention Type
Drug
Intervention Name(s)
Pentoxifylline
Other Intervention Name(s)
Trental
Intervention Description
added to vedolizumab
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
added to vedolizumab
Primary Outcome Measure Information:
Title
proportion of patients in clinical remission
Time Frame
week 14
Secondary Outcome Measure Information:
Title
number of new major and minor infections
Time Frame
week 24
Title
number of episodes of nephrotoxicity
Time Frame
week 24
Title
number of episodes of hepatotoxicity
Time Frame
week 24
Title
number of episodes of myelosuppression
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar R Deshpande, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Synergistic Effect of Vedolizumab and Pentoxifylline

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