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.

About this Study

The proposed study will 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 in Crohn's Disease (CD) subjects at higher risk for CD complications.

Sponsor Protocol ID:009125
IRB Number:2019-0268
Actively Enrolling
Interventional
Phase 4
January 08, 2020
Eligibility Criteria
18 years old
65 years old
Both Male and Female
No
No
No

Inclusion Criteria
  • Adult subjects, aged 18 to 65 years at time of screening. 
  • CD diagnosed in the previous 24 months prior to screening. 


Exclusion Criteria
  • Subjects who have any evidence of active infection during Screening
  • History of congestive heart failure 

Categories Click category to view its trials.
Digestive Conditions
Participating Locations
Belhaven - University Physicians
University Hospital
Contact Information
Contact Name: Yilianys Pride
Phone Number: 601-496-2009
Email: ypride@umc.edu
Principal Investigator:Glover, Sarah C, D.O.
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