“Triple Combination Therapy in High Risk Crohn's Disease (CD)”
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Drug - Vedolizumab
Vedolizumab intravenous infusion.
Drug - Adalimumab
Adalimumab injection for subcutaneous use.
Drug - Methotrexate
Methotrexate oral tablets.
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