NCT02953275

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Apr 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 13, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

October 31, 2016

Last Update Submit

July 9, 2019

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • proportion of patients in clinical remission

    week 14

Secondary Outcomes (4)

  • 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

Study Arms (2)

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.

Drug: vedolizumabDrug: Pentoxifylline

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.

Drug: vedolizumabDrug: placebo

Interventions

vedolizumabDRUG

standard of care

Also known as: Entyvio
vedolizumab plus pentoxifyllinevedolizumab plus placebo
PentoxifyllineDRUG

added to vedolizumab

Also known as: Trental
vedolizumab plus pentoxifylline
placeboDRUG

added to vedolizumab

vedolizumab plus placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Crohn's and Colitis Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

vedolizumabPentoxifylline

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

TheobromineXanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Amar R Deshpande, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 2, 2016

Study Start

April 13, 2017

Primary Completion

March 18, 2019

Study Completion

June 13, 2019

Last Updated

July 11, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)