Synergistic Effect of Vedolizumab and Pentoxifylline

NCT ID: NCT02953275

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-13
• Study Completion Date: 2019-06-13

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

vedolizumab

Intervention Type: DRUG

standard of care

Pentoxifylline

Intervention Type: DRUG

added to vedolizumab

vedolizumab plus placebo

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

Group Type: PLACEBO_COMPARATOR

vedolizumab

Intervention Type: DRUG

standard of care

placebo

Intervention Type: DRUG

added to vedolizumab

Interventions

vedolizumab

standard of care

Intervention Type: DRUG

Pentoxifylline

added to vedolizumab

Intervention Type: DRUG

placebo

added to vedolizumab

Intervention Type: DRUG

Other Intervention Names

Entyvio; Trental

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Amar Deshpande

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amar R Deshpande, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Crohn's and Colitis Center

Miami, Florida, United States

Countries

United States

Other Identifiers

20160543

Identifier Type: -

Identifier Source: org_study_id