An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy with Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects with Crohn's Disease Stratified at Higher Risk for Developing Complications
ID Number 17-0974Principal Investigator(s)
James F Marion
Department(s) or Division(s)
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab IV), a tumor necrosis factor (TNF) antagonist (adalimumab SC), and an immunomodulator (oral methotrexate) on endoscopic remission at Week 26.
Subjects may qualify to take part in this research study because they have a diagnosis of Crohn's Disease established within 18 months prior to enrollment with of the ileum and/or colon that can be assessed by ileocolonoscopy.
Subjects will be screened, up to 28 days, prior to enrollment and undergo a series of tests to determine if they are eligible for the study.
During the study drug treatment period, subjects will receive triple combination therapy (300 mg vedolizumab IV, 160/80/40 mg adalimumab SC, and 15 mg oral methotrexate).
Subjects will not be randomized in this study.
Subjects participation in this research study is expected to last a maximum of 924 days/132 weeks.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 60.
Recruiting Patients: Yes