Synergistic Effect of Vedolizumab and Pentoxifylline

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT02953275

Run by

University of Miami

People needed

37

Starts

2017-04-13

Expected to finish

2019-06-13

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Crohn's and Colitis Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.