Synergistic Effect of Vedolizumab and Pentoxifylline

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02953275
• Date of registration: 31/10/2016
• Prospective Registration: Yes
• Primary sponsor: University of Miami
• Public title: Synergistic Effect of Vedolizumab and Pentoxifylline
• Scientific title: Synergistic Effect of Vedolizumab and Pentoxifylline in the Management of Patients With Inflammatory Bowel Disease
• Date of first enrolment: April 13, 2017
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02953275
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Amar R Deshpande, MD
• Affiliation: University of Miami

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: vedolizumab

Drug: placebo

Drug: Pentoxifylline

Primary Outcome(s)

proportion of patients in clinical remission [Time Frame: week 14]

Secondary Outcome(s)

number of episodes of hepatotoxicity [Time Frame: week 24]

number of new major and minor infections [Time Frame: week 24]

number of episodes of myelosuppression [Time Frame: week 24]

number of episodes of nephrotoxicity [Time Frame: week 24]

Secondary ID(s)

20160543

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda