The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness

Completed

Conditions studied: Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

In brief

Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.

Key facts

Study ID

NCT02423512

Run by

Icahn School of Medicine at Mount Sinai

People needed

50

Starts

2015-06-01

Expected to finish

2017-06-13

Last updated by the study team

2017-09-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female adults with a diagnosis of inflammatory bowel disease
• Patients who will be started on vedolizumab therapy as clinically indicated and in discussion with their treating physician will be eligible. Patients will not be started on vedolizumab for the sole purpose of this study

You may not qualify if…

• Patients with prior exposure to vedolizumab or natalizumab

Where it is running

• Susan and Leonard Feinstein Inflammatory Bowel Disease Center — New York, New York, United States

Full record on ClinicalTrials.gov

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