Study to Evaluate Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Crohn’s Disease (H-39516)
What is the purpose of this study?
The purpose of this study is to evaluate the efficacy and safety of triple combination therapy for remission and endoscopic healing followed by Vedolizumab IV monotherapy to maintain remission for 76 weeks.
Who is eligible to participate?
Newly-diagnosed Crohn's Disease (Must be diagnosed within the last 24 months)
Moderately to Severely active CD with moderate to high risk for complications
No prior exposure to biologic treatment
No prior exposure to Tuberculosis ·
Willing to return every 4 to 8 weeks for study visits for duration of the study (102 Weeks)
The study coordinator will review medical and eligibility requirements by phone while setting up the first appointment. A consent form will be provided at the initial visit.
Study Enrollment Closure Date Enrollment Closing on March 31, 2020
What is involved?
Subjects participating in the control project will be asked to make annual clinic visits at Baylor College of Medicine, located on the 8th floor of the McNair Building, 7200 Cambridge St, Houston, TX 77030. At the initial visit, a consent form explaining the study will be presented. Eligible subjects will be asked questions about their medical history and current medications. Subjects will also be given a brief physical exam (including vital signs) and routine blood work. The clinic visit will take about three and half hours. Once enrolled in the study, each subject will be asked to return monthly. Visits could include, vital signs, exams, brief questionnaires, blood work, stool samples, ECG, Colonoscopy (Three times throughout the study) and infusion.
How much will this cost?
All research related procedures are FREE to you. Stipend for travel and time will also be included.