Synergistic Effect of Vedolizumab and Pentoxifylline

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: vedolizumab; Drug: Pentoxifylline; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Crohn's and Colitis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: vedolizumab plus pentoxifylline; Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.	Drug: vedolizumab; standard of care; Other Names: Entyvio; Drug: Pentoxifylline; added to vedolizumab; Other Names: Trental
PLACEBO_COMPARATOR: vedolizumab plus placebo; Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.	Drug: vedolizumab; standard of care; Other Names: Entyvio; Drug: placebo; added to vedolizumab

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Takeda
• Investigators: Principal Investigator: Amar R Deshpande, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 13, 2017
• Primary Completion (ACTUAL): March 18, 2019
• Study Completion (ACTUAL): June 13, 2019

Study Registration Dates

• First Submitted: October 31, 2016
• First Submitted That Met QC Criteria: October 31, 2016
• First Posted (ESTIMATE): November 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Gastrointestinal Agents; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Vedolizumab; Pentoxifylline
• Other Study ID Numbers: 20160543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No