Synergistic Effect of Vedolizumab and Pentoxifylline

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953275
• Other study ID #: 20160543
• Status: Completed
• Phase: Early Phase 1
• Start date: April 13, 2017
• Est. completion date: June 13, 2019

Study information

• Verified date: July 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 13, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• vedolizumab
standard of care
• Pentoxifylline
added to vedolizumab
• placebo
added to vedolizumab

Locations

Country	Name	City	State
United States	University of Miami Crohn's and Colitis Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients in clinical remission		week 14
Secondary	number of new major and minor infections		week 24
Secondary	number of episodes of nephrotoxicity		week 24
Secondary	number of episodes of hepatotoxicity		week 24
Secondary	number of episodes of myelosuppression		week 24