Crohn Disease
Conditions
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.
Interventions
DRUGPentoxifylline
added to vedolizumab
DRUGplacebo
added to vedolizumab
DRUGvedolizumab
standard of care
Sponsors
Takeda
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of patients in clinical remission | week 14 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed