Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Miami
With
Takeda
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
