Clinical Trial

Triple Combination Therapy in High Risk Crohn's Disease (CD)

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Vedolizumab

Vedolizumab intravenous infusion.

Drug - Adalimumab

Adalimumab injection for subcutaneous use.

Drug - Methotrexate

Methotrexate oral tablets.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT02764762

ParticipAid ID

oeEXWd