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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
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
Address: 
Telephone:
Email:
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: Pentoxifylline
Drug: placebo
Drug: vedolizumab
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 episodes of myelosuppression [Time Frame: week 24]
number of episodes of nephrotoxicity [Time Frame: week 24]
number of new major and minor infections [Time Frame: week 24]
Secondary ID(s)
20160543
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Takeda
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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